From the Bureau Archives - European Industrial Pharmacists Group (EIPG)

EIPG Meeting in Rome in April


By Piero Iamartino The 2024 General Assembly of EIPG (European Industrial Pharmacists Group) was held in Rome on 20 and 21 April. Delegates from 14 European professional organisations joined EIPG, representatives of two other organisations were observers, and a few Read more

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

EIPG Meeting in Rome in April

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By Piero Iamartino

The 2024 General Assembly of EIPG (European Industrial Pharmacists Group) was held in Rome on 20 and 21 April. Delegates from 14 European professional organisations joined EIPG, representatives of two other organisations were observers, and a few guests were present.

The General assembly was preceded by a conference on Friday, 19 April, arranged with the support of AFI (Associazione Farmaceutici Industria) on “Medicines Shortages and Lists of Critical Medicines” held in the Nobile Collegio Chimico Farmaceutico. Domenico Di Giorgio (AIFA and CHESSMEN Coordinator) was the chairman of this special event with the presence of representatives of agencies from Portugal, Finland and Spain who were speakers and panel members, together with representatives from the research pharmaceutical (Farmindustria) and the generic pharmaceutical (Egualia) industries in Italy.

As several EIPG guests from Medicines for Europe, EFPIA, the community and hospital pharmacists representing PGEU and EAHP, and the parallel trade association (AME) were interested in attending the Friday Conference, our Bureau took the opportunity to hold a meeting with them to discuss possible joint activities over the next year.

President Piero Iamartino opened the General Assembly, highlighting the significant strides made by EIPG since the last annual meeting. These achievements included EIPG’s enhanced relationships with other professional organisations in the pharmaceutical arena and EMA’s recognition of EIPG as an interested party regularly invited to attend meetings and initiatives open to stakeholders. Notably, he mentioned EIPG’s contribution to the meeting with EMA/IWG on 7 March, where a discussion on a few GMP/quality topics and their compliance implementation occurred. He also announced that EIPG was now among the 250 members of the CMA (Critical Medicines Alliance), a testament to our commitment to fight shortages according to the recent European Commission plan. At the end of his speech, the President highlighted the successful result of the first initiative of a professional training course promoted by EIPG at the European level focused on implementing Annex 1 requirements.

The activity report was integrated with the Vice Presidents’ presentations. Astrid Thorissen (VP of Education and Career) reported on the positive feedback received on the EIPG concept paper on new competencies requested from the industrial pharmacist and gave an update on the interactions with the European pharmacy students (EPSA) and the European pharmacy academics (EAFP), confirming the development of initiatives to promote awareness of industrial pharmacist profile requirements.

The impact of artificial intelligence on the industrial pharmacist’s role was one topic presented by Anni Svala (VP of European Affairs), who referred to a first paper highlighting the key issues recently prepared and published on the EIPG website. She also reported on the position paper of EIPG about the revised pharmaceutical legislation and the commitment to monitoring its impact on the activities of industrial pharmacists.

With the contribution of Maurizio Battistini (Treasurer and past VP of European Affairs), it was recalled several initiatives on the medicine shortages issue where EIPG has been involved during the last few years and the willingness to continue its contribution with new actions was confirmed.

In the absence of Rebecca Stanbrook (VP of Technical and Professional Development), Piero Iamartino highlighted, among other activities, EIPG’s participation as an official member in the multi-stakeholder platform on Accelerated Clinical Trials (ACT), an EMA initiative with the final goal of increasing the number of clinical trials in Europe.

An updated overview of the EIPG communication tools and their impact was the object of the presentation by Giorgos Panoutsopoulos (VP of Communications), who showed, in particular, the significant increase of interest in EIPG news based on the data collected over the last year. He also reported on the successful choice of hot topics for the proposed webinars and the issue of the EIPG newsletter covering different areas of competence for industrial pharmacists.

At this year’s General Assembly, EIPG invited three speakers to present and discuss topics of interest.

Raffaella Vaiani (ISPE-Italy Affiliate) talked about the “Digital Revolution in Pharma”, Sini Eskola EFPIA) “The Changing European Regulatory Framework” was presented, and Antonio Conto (a toxicologist from Chemsafe) presented the “New Scientific Approach to ERA” (Environmental Risk Assessment).

These presentations were followed by two working groups: one considered the changing profile of industrial pharmacists, continuous education, and digital transformations, and the second looked at the contribution of industrial pharmacists to pharmaceuticals’ environmental sustainability. At the end of their work, both groups presented some proposals for actions that were considered to prepare the EIPG updated strategic plan for 2024-2025.

At this General assembly, Carmen Garcia, a Spanish delegate, was elected Vice President of Technical and Professional Development for three years, while Anni Svala was confirmed Vice President of European Affairs. Rebecca Stanbrook was thanked for her two years of work on technical and professional development.

Paul Andreianu (observer) presented the Romanian newly formed Associations of Industrial Pharmacists (AFFI) application for full membership of EIPG. The Romanian Industrial Pharmacists Forum was welcomed with acclamation and congratulations. Next year’s General Assembly will be held in Madrid during May.


A new member within EIPG

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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 Dr Piero Iamartino said: “Development and representation of the industrial pharmacist in Europe is the central mission of EIPG. The additional participation of every new member country in our Association’s activity therefore helps us further fulfil our goals and achieve pan-European cooperation in raising standards of industrial pharmaceutical practice. The diversity of our association grows and enables continuous improvement in lesson-learning and best-practice sharing across Europe. I have been deeply impressed already with the professionalism of our Romanian colleagues and look forward to many fruitful years of working together.”

Paul Andreianu, AFFI’s delegate to the EIPG General Assembly said: “Membership of EIPG offers industrial pharmacists in Romania a real opportunity to be involved and influence pan-European efforts directed at raising standards in pharmaceutical practice, in all parts of this complex and highly regulated environment. There is much for Romania to contribute to this respect and I look forward to myself and the AFFI team being active and engaged in those conversations and activities.”


Environmental sustainability: the EIPG perspective

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Piero Iamartino

Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the 2000s that specific regulatory interventions have been designed to promote the identification of the different sources of pollution and the determination of possible actions to be taken.

The obligation to submit the result of an environmental risk assessment of a medicinal product at the same time as the application for marketing authorisation was introduced only after the publication of the Environmental Risk Assessment (ERA) guideline issued by EMA in 2006, which sets out the guidelines and describes a series of standard tests to be performed. However, this first piece of legislation immediately highlighted limitations as it was applied only to the marketing of medicines from that moment on, without considering the contribution of medicines with the same active ingredient and neglecting the evaluation of those already authorised and on the market.

Over the following years, the problem of the environmental impact of medicines was tackled more extensively with the launch of several projects promoted by the European Commission in partnership with the EFPIA (IMI: Chem21, iPiE and Premier) which have deepened the characterisation of environmental risks, with the identification of priority criteria to be assigned to interventions and the development of models and tools to measure the sustainability of the processes of manufacture, in particular of active substances.

These important projects in recent years have been added to the initiatives undertaken at the European level with the publication in 2020 of the new European pharmaceutical strategy which defines some specific objectives for the mitigation of the environmental impact of medicines that will be reflected in the upcoming revision of European pharmaceutical legislation and which are part of the broader regulatory acts for the ecological transition envisaged by the Green Deal European.

In light of the above, a gradual transformation of some processes and operating methods carried out by the European pharmaceutical industry is envisaged, starting from the development of a new medicinal product to its distribution and, similarly, adequate regulatory interventions will have to be envisaged on the management of the correct use and disposal of medicinal products since the environmental impact of this last phase of the life cycle of a medicinal product is predominant.

Although these changes involve all professionals working in the pharmaceutical industry, a key role is played by the industrial pharmacist who, due to his professional profile dictated by his university curriculum, has the fundamental knowledge bases to occupy different positions in the industry, covering the entire path of medicine from its conception and manufacture as an active ingredient, its development as a medicinal product and its distribution on the market.

With this in mind, EIPG has started the preparation of a document that analyses the main critical areas of the entire production process of a medicinal product and sets out its position on the interventions considered a priority in a perspective of changes that will lead to the inclusion of new methods alternative material resources and will require new skills.

The first critical area examined is the manufacture of the active ingredient, both for its impact as such on the environment and for the process applied to its manufacture. The problem is particularly relevant for small molecules, while it is substantially insignificant for large molecules and even less so for products based on the use of cellular tissues or biological structures (ATMPs). The fundamental parameters to be considered are the environmental toxicity and the bio-degradability of the product. The problem is how to reconcile these two parameters with the chemical-physical and biopharmaceutical characteristics that an active ingredient must possess to be administered, absorbed and then carry out the desired pharmacological activity. The effort required in the design and screening phase of a new small molecule is the identification of a structural parameter that makes it more eco-friendly without compromising its purpose. Although this criticality does not arise in the case of large molecules and ATMPs, for these active ingredients the environmental impact due to higher energy consumption attributable to the need for low-temperature storage conditions may prevail.

About the production process of small molecules, which today still represent the largest percentage of active ingredients in development and on the market, it is essential to definitively introduce the application of the principles of Green Chemistry, as highlighted by the most recent studies (IMI Premier Project). The prospect is that of a progressive change in the synthesis processes with the use of reagents and less toxic solvents that are entirely recyclable and reusable, as well as the development of a synthesis route that allows the least number of operations, generating the least amount of waste and maintaining the best possible efficiency. It is desirable to increase biocatalysis processes as well as the introduction of more incisive treatments in the management of industrial wastewater to accentuate chemical degradation before their transfer to eternity.

A second large critical area where important changes are expected is the manufacturing processes of the medicine from the active substance to its availability for distribution on the market. Also in this area, interventions can be identified to optimize the use of the resources used, with particular reference to energy consumption and the use of water. These two parameters are already the subject of numerous studies for the development of new energy containment processes with the introduction of innovative plant solutions, and further improvements are expected considering the benefits that derive from them in terms of efficiency and therefore costs.

Among the parameters closely linked to the medicinal product that shows a significant environmental impact, attention must be paid to the packaging materials used in the pharmaceutical industry. A priority intervention must focus on certain widely used plastic materials that are difficult to dispose of and not recyclable, identifying alternative materials with the consequent need to study their compatibility with the medicinal product, especially if used in direct contact, and their impact on the stability profile of the same, as required by the reference standards. Other objectives should be the choice of secondary packaging materials that can be easily recycled by the end user, as well as the reduction of their volume, also favoured by the digitization of the information materials related to them. The implementation of these interventions will require adjustments both to the packaging lines used in the pharmaceutical industry and to the alternative ways of managing products in the transport and distribution phase, with a marked increase in studies for the reuse of packaging materials in line with the principles of the circular economy.

The prospects of the expected changes in the path from the active substance to the medicine will have to be accompanied by an assessment of the possibilities of intervening in the supply chain used by the pharmaceutical industry involving suppliers of active ingredients, materials and medicines. The regulatory guidelines and commitments on actions to improve environmental sustainability will require a progressive review in the management and evaluation of suppliers according to their ability to apply the ecosustainability criteria of their processes, giving preference to those who take this path.

The above analysis, limited to the areas of greatest environmental criticality, highlights the transformations that are expected in the pharmaceutical industry in the coming years with the implementation of the provisions that will be progressively adopted at the European level. We think there should be good coordination between the impositions for environmental sustainability and the need to adhere to pharmaceutical regulatory requirements to facilitate the implementation of changes. This coordination is essential as innovation will be the guiding criterion for the introduction of the required changes to meet the sustainability objectives.


How AI is Changing the Pharma Industry and the Industrial Pharmacist’s Role

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Svala Anni, Favard Théo, O´Grady David

The pharmaceutical sector is experiencing a major transformation, propelled by groundbreaking drug discoveries and advanced technology. As development costs in the pharmaceutical industry exceed $100 billion in the U.S. in 2022, there is a pressing need for innovative solutions to accelerate drug development. The urgency stems from a renewed focus on novel approaches, driven by the complexities of advanced therapeutic modalities like mRNA, CGT, and synthorins. This blog delves into the influence of Artificial Intelligence (AI) on overcoming the unique hurdles within the manufacturing domain of the pharmaceutical industry. It specifically emphasizes the crucial partnership between AI and human expertise, shedding light on the vital role of industrial pharmacists in optimizing manufacturing processes.

The demands for precision, quality, and compliance in pharmaceutical manufacturing present challenges, notably in managing rising costs and intricate logistical processes. The adoption of various AI technologies, including generative AI (GenAI), represents a strategic shift, aiming to augment human capabilities while automating routine tasks and facilitating knowledge transfer in the ever-evolving landscape of pharmaceutical production

The fourth industrial revolution is upon us with the development of cyber physical systems and the fifth industrial revolution is on the horizon with the advancement of artificial intelligence (AI) in partnership with humans to enhance workplace processes. The factory of the future is here with digitalization, AI, Big data, robotics and advanced manufacturing becoming the norm rather than the exception in the pharmaceutical industry.

GenAI excels in promoting collaboration while surpassing traditional task automation. It is key in transmitting complex knowledge crucial for maintaining quality, compliance, and safety in pharmaceutical manufacturing. AI empowers experts to document processes using everyday devices, transforming this raw data into straightforward, visual instructional guides.

The pharmaceutical industry confronts distinct manufacturing challenges, including complex processes and rigorous regulatory standards. AI can offer several innovative and compliant solutions. In addition, AI platforms swiftly update training materials, creating dynamic learning environments that keep the workforce informed about the latest developments. These platforms are redefining roles by taking over mundane tasks, thereby freeing human workers to focus on more strategic and creative roles. Furthermore, AI guarantees uniform training across global operations, ensuring consistent processes and fostering global standardization.

Combining humans and AI creates a powerful team that may benefit everyone. AI helps make learning experiences unique for each person, fitting their own way of learning. It also makes it easy for people to get the information they need anytime, thanks to the latest tech advancements. AI is great at helping people from different cultures and who speak different languages work together better. It can give feedback right away, so mistakes don’t spread. Plus, AI holds onto valuable knowledge, reducing the chance of losing important information when people leave or retire. Together, all these benefits show how AI can make a big, notable change also in the pharmaceutical field.

AI – Shaping the Future of Pharmaceutical Industry

AI is transforming the pharmaceutical landscape, particularly in areas vital to industrial pharmacists, such as manufacturing, quality control, and distribution. These professionals play a pivotal role in skillfully integrating AI, serving as the human-in-the-loop to enhance efficiency and ensure safety in pharmaceutical operations.

AI elevates the manufacturing process, forecasts maintenance needs, and sharpens quality control. Industrial pharmacists are pivotal in deploying these AI-driven techniques, ensuring that operations are not only effective but also meet high-quality standards and regulatory requirements.

The Role of Industrial Pharmacists

Industrial pharmacists are essential contributors to this technological revolution, actively collaborating with data engineers and scientists. They play a pivotal role in ensuring regulatory compliance, upholding product quality, and leveraging AI to enhance drug development processes, inventory management, and distribution. Industrial pharmacists:

  • are essential in incorporating AI into manufacturing workflows.
  • ensure AI tools align with regulatory requirements and uphold product quality.
  • utilize AI to accelerate and economize the drug development process.
  • leverage AI for more effective inventory and distribution management.
  • analyze data generated by AI systems for informed decision-making in production and quality control.
  • ensuring the quality of pharmaceutical products, they play a crucial role in safeguarding patient safety.
  • leverage AI to identify eco-friendly manufacturing practices, contributing to sustainable pharmaceutical production.

Risks and Challenges

Using AI in the pharmaceutical environment involves navigating risks such as ensuring data privacy and security, maintaining regulatory compliance, addressing biases and ethical concerns, and dealing with the quality and reliability of data. Additionally, there are challenges related to intellectual property issues, integration with existing systems, scalability and maintenance, and dependence on external vendors. To effectively leverage AI benefits while minimizing these risks, a comprehensive strategy encompassing robust data governance, ethical AI practices, ongoing regulatory engagement, and careful technological and organizational change management is essential.

Conclusion

The pharmaceutical industry stands on the brink of a transformative era, driven by the profound potential of AI to reshape its landscape. The key to unlocking this potential lies in the proactive involvement of industrial pharmacists, who are urged to assume a more strategic and leading role in steering innovation.

Traditionally perceived as followers, industrial pharmacists now face a pivotal moment to transition into drivers of change. This isn’t merely a shift in perception; it is a call to action. The integration of AI offers a unique opportunity for pharmacists to shape the future of pharmaceutical care actively and courageously.

In this evolving landscape, industrial pharmacists are not just guardians of compliance but architects of efficiency, adaptability, and innovation. Collaborating seamlessly with AI technologies, they hold the power to propel the industry forward. Despite certain challenges, this collaboration looks promising – it isn`t just compliant and efficient but also dynamic and inventive.

The call to action is clear – pharmacists, especially those in industrial roles, are not merely spectators in this technological revolution; they are the forerunners, charting a course towards a more responsive and innovative pharmaceutical future.

References:

Artificial trends: intelligence in the pharmaceutical industry: analyzing, innovation, investment and hiring

Insights to the Industrial Pharmacist role for the future: A concept paper from EIPG Advisory Group on Competencies, vol 2, 2023

Pizoń J, Gola A. Human–Machine Relationship—Perspective and Future Roadmap for Industry 5.0 Solutions. Machines. 2023; 11(2):203.

Zheng, S. (2023, Nov. 2). “Empowering the pharma workforce.” Pharma Manufacturing.

Contact for further information:
Anni Svala, Vice-President for European Affairs, European Industrial Pharmacists Group, [email protected]


Webinar: Oral Colon Drug Delivery – Design Strategies

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EIPG webinar

Next EIPG webinar is to be held on Wednesday 21st of February 2024 at 17.00 CET (16.00 GMT) in conjunction with PIER and University College Cork. Anastasia Foppoli, will discuss on the various approaches and the general aspects relevant to the design and technological features of colon drug delivery systems, for the local treatment of inflammatory bowel diseases the control of colonic bacterial growth and the improvement of the bioavailability of orally administered polypeptides and proteins.

Increasing interest is directed to delivery systems able to control the site of release. In this respect, colon drug delivery has been suggested for the local treatment of inflammatory bowel diseases, the control of colonic bacterial growth and the improvement of the bioavailability of orally administered polypeptides and proteins. Various approaches have been attempted including the use of prodrugs, coatings degraded by microflora enzymatic activity, and polymeric coatings which dissolve at specific pH. Another strategy relies on the exploitation of the relative constant small intestine transit time of pharmaceutical dosage forms. This talk includes the rational basis for various approaches, the general aspects relevant to the design and technological features of colon drug delivery systems, together with their classification and definition.

Anastasia Foppoli is Associate Professor at the School of Pharmacy, University of Milan.
After graduating in Chemistry and Pharmaceutical Technology at the University of Milan in 1998, she earned a PhD from the University of Cagliari. In 1999, she attended the School of Pharmacy of the University of Minnesota as a visiting scientist, dealing with the study of solid-state properties of drugs and excipients. She is the author of more than 60 publications, including research papers, reviews, book chapters and patents in the drug delivery area, and presented numerous lectures at national and international conferences. Her current research interests, within GazzaLaB Research group, concern the design and preparation of conventional as well as modified release oral dosage forms. She serves on the Editorial Advisory Board of Journal of Pharmaceutical Sciences (Elsevier, Amsterdam, NL) and Pharmaceutics (MDPI, Basel, CH), and is peer reviewer for several major journals in the field of pharmaceutical technology. She is member of SITELF, SCI, CRS Italy Local Chapter and AFI.

By the end of this webinar, you will be able to:

  1. Understand the rational for colon delivery.
  2. Define the various physiological determinants to the design of colon delivery systems.
  3. Compare the different approaches proposed, criticalities and limitations.
  4. Be informed on well-established and emerging technologies involved in the manufacturing of colon delivery systems.
  5. Recognize the possible regulatory impact of colon delivery systems

Please register by filling out the Registration Form. Keep a record of the streaming details of the event that will be shown on your screen at the time of your registration.


EIPG Training Course: Annex 1

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Dear colleagues,

I am very pleased to announce the GMP/Annex 1 Professional Training Course which will be held as 8 webinars of about 2 hours each from the 3rd of April to the 29th of May (one module per week except 1st of May).

EIPG took care of defining the training plan, which is divided into 8 modules covering the entire contents of GMP/Annex 1, and the identification of the trainers who are all highly qualified professionals with specific experience in sterile medicinal products manufacture and control.

EIPG agreed with all trainers that for each module, the text of a few chapters/paragraphs of Annex 1 be presented, explained and commented focusing on the critical requirements and describing the implementation solutions with examples.

A Q&A section will be open as a chat during the training module and all trainers will ensure the presence of time slots for replying to the questions.

EIPG has found MakingLife Srl, an Italian innovative communication company, as a qualified partner to entrust all organizational, technical and commercial features for making this EIPG training course possible.

Training Course: Annex 1

Though this training was mainly developed for industrial pharmacists who are members of the associations joining EIPG, it is open to all professionals working in the pharmaceutical area who are interested in manufacturing sterile medicinal products.

As EIPG members, you are entitled to a discount of 25% of the price.

When you apply to buy the full course or single modules, you will have to put in a coupon number.

To get your coupon number you can use the following link to the MakingLife platform where you are requested to specify your name, association and e-mail address, which will be also used for the connection to the webinars:

To register yourself to this training courses, follow the below link.

You are invited to disseminate this announcement within your association promoting participation in this training course to your colleagues and also within your contact network with other professionals and non-EIPG members.

Piero Iamartino

President, European Industrial Pharmacists Group (EIPG)


The drug shortage situation – EIPG’s point of view

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by Maurizio Battistini

The shortage of medicines has been a major concern in the countries of the European Union, and elsewhere, for more than 10 years, so much so that the Economic Community has devoted a great deal of effort and increasing attention to this problem in an attempt to mitigate its impact on patient health.

Several factors can be identified as being at the root of the shortage of medicines, some of which intersect with each other, mainly concerning aspects with technical, qualitative, regulatory, forecasting, supply, speculative and economic implications.

EIPG has made its contribution to the various attempts to contain the phenomenon by participating in task forces, round tables and convenings dedicated to identifying the root causes of the issue and, through gap analysis, the consequent mitigation measures. Overall, strengthening the risk-assessment approach to assess and define the risk level of individual deficiencies or the causes to which they pertain in order to rationalize and focus mitigation interventions and identify their level of acceptance with a proactive approach.

Before defining the particularly deserving aspects to be emphasised and consequently acted upon, it is important to mention those that represent, in the opinion of EIPG, but are not limited to, the elements on which priority action should be taken. In analysing the problem, one cannot in fact fail to take proper account of the fact that medicines are not such without their active ingredients and that, for diseases with the widest spread, there are equivalent medicines and alternative therapies. On the basis of the latter assumption, it is understandable that the definition of a shortage of medicines should be restricted to cases where no equivalent medicines or alternative therapies with different medicines are available, so as to concentrate efforts to solve the problem only on those conditions that are worthy of attention because they are not limited to the unavailability of a specific product or to situations for which it is possible to identify an alternative treatment (defining a list of critical medicines and defining risk assessment criteria for assessing whether a product should be on the list or not).

The operation required to bring the production of active ingredients back to Europe, recognising their strategic and central role in the composition of medicines for the entire community and patients, takes longer. The relocation of the manufacturing of active ingredients to third countries, which has been taking place for several years now for mainly economic reasons, has led to the dependence of many other countries, including mainly those of the Union, on supplies that today has the occasional impact that we know of, but which could become much more serious if not systemic. We have been hearing about reshoring the production of active pharmaceutical ingredients for some time now, but so far there do not seem to be any concrete initiatives for its implementation.

As mentioned above, EIPG identified the revision of the definition of drug shortages and the reallocation of strategic production of active pharmaceutical ingredients in Europe as a main key action to mitigate the impact of drug shortages.

Although it is not an aspect of primary interest to the European industrial pharmacist community, EIPG recognises the economic aspects as playing an important role in the origin of shortages, particularly with regard to the low price paid for certain categories of medicines, which induces manufacturers to abandon the manufacture of low-profit products, and the discrepancies in the price of medicines that exist in the different countries of the Union, discrepancies that, coincidentally, make the countries where prices are the lowest or even where volumes are not so attractive as to devote production to shortages.

Having made this necessary digression on the aspects requiring corrective action at source, there are, however, other, mostly ‘occasional’ causes on which to intervene, where possible, in a proactive manner or by means of reaction instruments capable of reducing the impact of shortages. In this regard, some of the elements covered in the introductory part of this discussion, namely: technical-qualitative, regulatory, forecasting and speculative, are taken up and detailed.

As far as the technical quality aspects are concerned, given the vastness of such occasional events in the production cycle of a medicine, a separate, dedicated discussion should be devoted to them. In addition to a few examples, please refer to the chapter ‘Shortages Originating from Manufacturing‘ in the text ‘Pharmaceutical Supply Chains – Medicines Shortages‘ published by Springer and written by the same author as this article. The book, authored by experts in the field, provides an insight of relevant case studies and updated practices in Pharmaceutical Supply Chains (PharmSC) while addressing the most relevant topics within the COST Action Medicines Shortages (CA15105) and it covers uncertainty and risk aspects of supply chain management, carefully combining the scientific level with a pedagogical approach. In industry, proactive strategies such as the adoption of reserve stocks or back-up establishments can be adopted to make up for medicine shortages on an emergency basis, although the expense of sustaining these prudential approaches remains the main problem.

In a number of situations, shortages can occur due to underestimated sales forecasts or problems with the supply of raw materials, and in particular APIs.

A particular case in point is parallel trade, which by its very nature can have such contrasting effects that it has been dubbed ‘The double face of the parallel trade’. While on the one hand, this method is useful in dealing with shortages in a relatively short time (import in the country where the shortage needs to be filled and export from the country where the availability exists), on the other hand, it has often encouraged the migration of products from countries where they are cheap to others where they guarantee a higher margin, in which case it could be the source of the problem and not its solution.

Last but not least, it should be pointed out that the phenomenon of shortages has an economic implication, as it is more likely to affect drugs with low profitability or movements of drugs from countries with low margins or sales volumes to those with high margins or higher market shares.

Heads of Medicines Agencies and the European Medicines Agency on improving availability of human and veterinary medicines invited the EIPG to attend the key stakeholders’ table at the Workshop on Shortages Prevention Plan held on 1 and 2 March 2023. The EIPG was represented by Jane Nicholson and Maurizio Battistini. Staff from the EMA, the European Commission and members of national authorities presented their current initiatives and future plans. Representatives from the research and generics industry, wholesalers, pharmacists from the EIPG and PGEU, and several organizations representing patient groups had the opportunity to present and discuss ideas for shortage prevention, permanent market withdrawals, and shortage communication and transparency.

The meeting had breakthrough sessions on biosimilars (the EMA is publicly encouraging their use) immunoglobulins and veterinary medicines. The EIPG commented on the low prices of medicines that cause shortages and called for more accurate definitions of ‘medicine shortages’ and to focus efforts on essential product shortages where there is no equivalent medicine or alternative therapy to ensure patient access to adequate treatment.

Shown below is the action plan that EIPG submitted to the group at the meeting; an action plan that largely reflects what is the topic of this article.

  • Establish pro-active risk management plan
  • Prepare list of medicinal products of clinical importance that lack therapeutic alternatives • Undertake regular checks on market availability of alternative products especially those with low pricing due to cap measures
  • Criticality in the procurement of all starting materials with particular attention to APIs
    • How to mitigate?
  • Quality and manufacturing aspects that could have an impact on medicines’ shortages
    • How to manage them preventively?
  • Appropriate agreements on quality and capacity of CMOs
  • Need to review quality management systems throughout life cycle (including those for older products)
  • Consideration of batch release and transportation impact on the time to deliver products to the market
  • Review impact on production planning of potential weaknesses in sales forecasting

Everyone in industry agrees that problems of shortages are complex with no quick solutions, and it was interesting to hear staff from Agencies agree that one of the main problems of shortages for older products is the impact of low pricing of products by national healthcare systems. Also, product dumping of medicines at an extremely low price was mentioned as occurring in some countries and everyone present agreed this must not be tolerated. There were 100 participants in the main meeting room at the EMA and 200 who were connected online.

In opening the meeting, Emer Cooke Executive (Director EMA) explained the aim was to inform stakeholders about the HMA/EMA Task Force activities and deliverables and share stakeholders’ perspectives on ongoing and planned initiatives to address availability issues. She explained the long-term position of the EMA is to focus on prevention and to become more proactive, particularly since the EMA after Covid was given an extended mandate for emergency situations. The EU joint action for shortages has been launched to improve capacity at national level and the single point of contact (SPOC) working party is really helping to ensure suitable structures are in place to assist with shortages. The EMA is working with the European Commission, DG SANTE (medicinal products unit, quality, safety and innovation) and DG HERA (intelligence gathering, analysis and innovation unit) both of whom made presentations during the meeting.

In October 2023, released documents about Commission steps up actions to address critical shortages of medicines and strengthen security of supply in the EU.

The work done by the European community is aimed at addressing the shortages of the most critical medicines by emphasising the role of logistical aspects but overlooking certain critical elements that go beyond supply chain management and concern the upstream management of the concrete problems for which medicine shortages continue to occur (root causes). For the time being, the Commission seems to be oriented towards a predominantly top-down approach, even if there are spaces where opportunities for a multidisciplinary discussion involving all stakeholders in the supply chain are offered. However, it remains important to note that the Community is taking an active interest in the problem albeit adopting containment measures aimed at containing the problem rather than solving it at its root.

Given the role entrusted to Italy to find solutions to this important problem, the author is convinced that the face-to-face meeting that EIPG will have in Rome with the Italian Medicines’ Agency, on the occasion of the EIPG’s Annual General Assembly, will serve as a constructive basis for working together to find longer-term solutions to medicines’ shortages main causes.

Reference: Battistini, M. (2019). Shortages of Medicines Originating from Manufacturing. In: Barbosa-Povoa, A., Jenzer, H., de Miranda, J. (eds) Pharmaceutical Supply Chains – Medicines Shortages. Lecture Notes in Logistics. Springer, Cham. https://doi.org/10.1007/978-3-030-15398-4_5


Insights to the Industrial Pharmacist role for the future

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A concept paper from EIPG Advisory Group on Competencies vol.2, 2023

This paper is an update of the previous EIPG paper and intends to raise awareness of the changing requirements of the professional profile of Industrial Pharmacists for Pharmacists at any stage of their career who intend to pursue careers in the Pharmaceutical Industry and those involved in the education of Pharmacists to update the education provided accordingly.

This paper is aimed at Pharmacists at all stages of their careers, including Pharmacy students, early career Pharmacists and Pharmacists working in a sector other than the Pharmaceutical Industry. The considerations presented are based on the collective expertise of the group. Therefore, this paper should be consulted as a starting point and is not a complete discussion of Pharmacist knowledge, competencies and skills nor a comprehensive overview of the Pharmaceutical Industry.

The EIPG with responsibility for the Pharmaceutical World, decided to continue the Project of the Advisory Group of Competencies. They used as a baseline document the first version of the position paper from 2020, in order to update the missing or outdated areas in the Pharmaceutical Industry. By examining some new trends and evolutions in drug science and technology, they explained the opportunities and challenges that are likely to arrive. All this information is intended for those at any stage of their Pharmacy career who want to understand their potential within the Pharmaceutical Industry.

The target of the project is to evaluate and determine the roles where the Industrial Pharmacist will work in the future and what knowledge, competencies and skills are needed to fulfill the requirements in these future roles. It is a shared understanding that there are gaps in the current curricula, but academia cannot cover all the needs of the Pharmaceutical Industry. For this reason, the Advisory Group have made some recommendations and proposals to recognize and fill those gaps. Hence, Pharmacists will have a clear view of the various roles in the pharmaceutical life cycle, and will be able to identify areas to develop on order to secure selected roles in the industry. This document may also be helpful in differentiating Pharmacists from other professions when applying for these roles.

You may find the full paper here.


The New Pharmaceutical Legislation

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by Jane Nicholson

To celebrate the 70th Anniversary of the foundation of the Belgian Association of Industrial Pharmacists (UPIP-VAPI) a Seminar on “The New Pharmaceutical Legislation” was held on 8th September in the European Parliament. The meeting was arranged in conjunction with the General Assembly of the European Industrial Pharmacists Group (EIPG) with attendance from participants of at least 15 European countries.

Frank Peeters, President of UPIP-VAPI opened the meeting and Alexia Rensonnet, a Board Member, described the new legislation as the largest reform in the past 20 years. The existing directive and regulations are to be replaced by new legislation with the objective of creating a single market to ensure all patients have timely and equitable access to safe, effective and affordable medicines whilst continuing to offer an attractive and innovation friendly market for suppliers.

Lilia Luchianov, Policy Officer at DG Sante – European Commission, said that the new legislation envisaged a leaner regulatory environment through simplification, regulatory modernisation and digitalisation. There will be access to both innovative and established medicines and incentives for innovation so that European companies remain globally competitive. Regulatory responsibilities will be shared between the EU and Member States. As well as changes to the General Pharmaceutical Legislation there will be changes to the Orphan and Paediatric legislation. Pre-authorisation support and a faster approval process including “targeted approach” rather than the current “one size fits all” are proposed.

The proposed reduction of protection for innovative products and the market launch conditions were questioned by several participants. Some of the current challenges for the Commission were said to be that pricing, reimbursement and procurement are a national competence.

In response to the current growing concerns on shortages, the Commission’s suggestions include the publication of an EU list of critical medicines, improved coordination of monitoring, earlier industry notification of shortages and withdrawals, improved industry shortage prevention plans, stronger coordination by the EMA and more legislative powers for the Member States and the Commission. During the discussion period Maggie Saykali, Director of the European Fine Chemical Group challenged the Commission to provide economic conditions for the manufacture in Europe of raw materials used by the pharmaceutical industry. Rather than dependence on China or India, European supply of raw materials would enormously improve security of supply of pharmaceuticals as well as improve worldwide environmental sustainability.

Par Tellner, Director of Regulatory, Drug Development and Manufacturing for the European Federation of Pharmaceutical Industries and Associations presented EFPIA’s views on the proposed revision to the pharmaceutical legislation. Whilst he welcomed the opportunities for regulatory modernisation such as simplification of the EMA structure by reducing the Scientific Committees from 5 to 2 and abolishing product licence renewals there are a number of challenges ahead. These include the notable reduction of research and development incentives, the added burden for industry to implement environmental risk assessments and the actual root causes of non-availability of medicinal products in the markets of Europe.

Jean-Paul Pirnay, head of LabMCT, Queen Astrid Military Hospital presented the past present and future of bacteriophage therapy. Wherever you find bacteria, you find phages which have been used since 1923 with the establishment of the Phage Institute in Tblisi (GEO). Although abandoned in the West many years ago, the Russian USSR has kept using phage therapy. Some isolated laboratories have been further developing and using phages and it has been shown that you need a handful of phages to target one bacterial spp.

Jean-Paul’s laboratory has helped establish a phage bank in a controlled environment. A single phage API can be produced according to a monograph. Individual phages can then be mixed together to target a particular bacterium. 100 seriously ill patients with resistant bacteria have been treated in 35 hospital of 29 cities and 26 phages were found to be needed. Eradication of the target bacterial infection was found in 61% of cases. In addition, phages were found to be synergistic when used with antibiotics. Jean-Paul considers commercially viable broad spectrum phage cocktails may be produced in the future.”

Geert Verniers (Lector SCM and Researcher BM-expertise center VIVES University) and his colleague described the use of Drones in the transportation of medicinal products,biological samples and tissues. With traffic congestion on roads causing gridlock around many hospital centres and personalised medicines needing urgent delivery from one area to another, the use of drones for professional transportation is compelling. Various significant points for consideration were discussed. These included the type of drone, drone pilots and Cargo Ports, the design of routes and the complexity of regulation, environmental impact, vibration problems and temperature control.

Following a lengthy discussion period, Frank Peeters thanked the speakers for their interesting contributions and all those responsible for this meeting being held in the European Parliament.


EIPG General Assembly and Elections 2023

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At the General Assembly held on 10th September in Brussels, voting took place for the positions of EIPG Treasurer and Vice-Presidents of Communications, European Affairs and Education and Careers.

The delegates present at this annual meeting elected Maurizio Battistini as Treasurer for the next two-year mandate. Giorgos Panoutsopoulos was elected to the position of Vice-President of Communications for the next 3 years, Anni Svala as Vice-President of European Affairs for 1 year and Astrid Thorissen as Vice-President of Education and Careers for 3 years.

Piero Iamartino presented the Past- Presidents award to Claude Farrugia for his exceptional contribution as President for two mandates. Jean-Pierre Paccioni was presented with a President’s Award for his valuable support with administrative operations in EIPG. In their absence from the meeting, an Outstanding Services award was made to Brigitte Saunier for her contribution to the financial management and a President’s award was made to Patrick O’Dwyer for his flawless technical support in the organisation of our webinars from University College Cork.

President Piero Iamartino together with the rest of the Bureau highlighted the main strategic objectives and confirmed their commitment to developing and promoting the position of the industrial pharmacist in Europe.