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

The risk of a biosimilar void in Europe


by Giuliana Miglierini The undergoing revision of the pharmaceutical legislation aims, among others, to redefine data protection to better support competitiveness of generics and biosimilars and to favour the timely access of patients to treatments. While the innovator pharma industry is Read more

The drug shortage situation - EIPG's point of view


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 Read more

EP’s draft position on Unitary SPC and SPC Regulation revision


by Giuliana Miglierini The Committee for Legal Affairs (JURI) of the European Parliament released the draft amendments to the Commission’s proposals aimed to establish a Unitary Supplementary Protection Certificate (SPC) (links to the document and to the procedure) and to Read more

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.


The Interface between Pharmaceutical Products and Medical Devices from a Product Development perspective

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EIPG webinar

Next EIPG webinar is to be held on Monday 26th of June 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork and is entitled “The Interface between pharmaceutical products and medical devices from a product development perspective“ by Janet Halliday.

Janet qualified as a pharmacist and has spent her whole career in the Pharmaceutical Industry. After 10 years working in various technical roles in formulation and process development Janet moved into senior leaderships roles. This involved both Scottish based projects and leadership of a global team examining novel Drug Delivery technologies from academic groups and startups. Janet retired from Ferring Controlled Therapeutics in December 2022 and continues to pursue interests in startup companies and guidance for Life Scientists at the beginning of their careers.

The webinar will address the following topics:
– An overview of the classification systems for devices in Europe and the USA;
– Definition of combination products;
– Challenges to consider when developing prefilled pens, polymer controlled delivery systems and patches;
– Definitions of standard terminology that can cause confusion in product development teams;
– Timings of development steps in Devices and Pharmaceutical products.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


General Assembly 2022: Bureau elections

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At the General Assembly held on October 15-16 in Athens, voting took place for the positions of EIPG President and Vice-President of Technical and Professional Development.

The delegates present at this annual meeting elected Piero Iamartino as President for the next three-year mandate. Rebecca Stanbrook was elected to the position of Vice-President of Technical and Professional Development. Brigitte Saunier completed her term of office as Treasurer and was thanked for her valuable support. Maurizio Battistini, Vice-President of European Affairs will act as EIPG Treasurer until the next General Assembly.

Claude Farrugia who has been President for two mandates and previously Vice -President of Communications was warmly thanked for his significant contribution to the progress EIPG has made in recent years as a reputable professional association recognised by the European Health Authorities.

The new President together with the current Vice-Presidents highlighted their main strategic objectives confirming their full commitment to developing and promoting the position of the industrial pharmacist in Europe.


Webinar: Implementation of Contamination Control Strategy Using the ECA template

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The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 21st of October 2022 (16.00 CEST), on the implementation of Contamination Control Strategy (CCS) using the ECA* template. This is the second presentation on the CCS, given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.

Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality. Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulate contamination.

The presentation explains the implementation of a CCS across a facility and deep dive into the ECA guideline on CCS. An example of CCS implemented by various manufacturers and the ECA CCS template will be presented. This will be followed by a discussion around the future challenges manufacturers may face with the principle of a holistic approach and how novel technology and data science combined with statistics may help in overcoming the future challenges.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.

  • European Compliance Academy

 


Webinar: Contamination Control Strategy, an Implementation Roadmap

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The next EIPG webinar will be held in conjunction with PIER and University College Cork on Friday 23rd September 2022 (16.00 CEST), on the implementation roadmap of Contamination Control Strategy (CCS). This presentation is given by Walid El Azab, Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation, an Industrial Pharmacist and a Qualified Person (QP), member of the ECA task force on the revision of Annex 1 and leading expert on the subject.

Manufacturers are required to develop a set of control strategies to confirm their process performance and product quality (EU Annex 2, EU Annex 14, USP1115, USP1116, FDA aseptic guideline, ICH Q10, Q11). The draft Annex 1 introduces a “Contamination Control Strategy” (CCS) approach to ensure process performance and product quality by preventing microorganisms, pyrogens, and particulates contamination.

The presentation explains the implementation of a CCS across a facility. It proposes an implementation roadmap to formulate and deploy a successful CCS. Also, it discusses the processes and environments that must be scanned to formulate a CCS. Then, the presentation proposes a method to make the strategy work as intended by implementing the correct control strategies. Finally, it discusses how a company can assess its CCS level over time and improve it.  During the presentation, an online survey will be launched to assess CCS implementation practices amongst the attendees.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.

 


Webinar: Implications and Opportunities of ICHQ2(R2) and ICHQ14

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The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 15th June 2022 (17.00 CEST), on the implications and opportunities of the revision of ICHQ2 (on validation of analytical procedures) and the ICHQ14 (on analytical procedure development). Our speaker Phil Borman, Director and Senior Fellow at GlaxoSmithKline, pioneered the adaptation of Quality by Design principles to analytical procedures and currently co-leads the EFPIA ICH Q2(R2) and ICH Q14 guidance on Quality by Design, will explain why these guidelines are being developed and will highlight their implications and opportunities.

The revision of ICHQ2(R1): Validation of Analytical Procedures and the development of ICHQ14: Analytical Procedure Development reached the key ICH milestone of Step 2 publication for public consultation in March 2022. The combined topic Q2(R2)/Q14 represents an opportunity to provide guidance on how to apply enhanced development approaches (‘Quality by Design’) to analytical procedures and how to use the knowledge obtained to support routine use of procedures. Q2(R2)/Q14 will also have the potential to facilitate the selection or identification of development approaches that will reduce the risk incurred by post-approval changes to analytical procedures discussed in ICHQ12: Pharmaceutical product Lifecycle Management. This webinar will explain why these guidelines are being developed as well as highlighting the implications and opportunities.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.


Continuous Manufacturing of Pharmaceuticals: Higher Quality, Greater Flexibility

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The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 30th March 2022 (17.00 CEST), on Continuous Manufacturing of Pharmaceuticals. Giustino Di Pretoro a subject matter expert and drug product development lead will provide his expert practical experience of continuous manufacturing. Our speaker is Giustino Di Pretoro the Scientific Director at Janssen Pharmaceutica, a Johnson & Johnson Company. He is a subject matter expert and drug product development lead for continuous manufacturing, and coordinator for a series of academic collaborations within the field.

For more than 50 years, pharmaceuticals have been produced using a method known as “batch manufacturing,” a multi-step, lengthy process that usually involves the use of large-scale equipment. However, recent advances in manufacturing technology have prompted the pharmaceutical industry to consider moving away from batch manufacturing to a faster, more efficient process known as “continuous manufacturing”. The Regulatory Agencies are taking proactive steps to facilitate the pharma industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and to address many of the underlying causes of drug shortages and recalls. Our speaker will provide his expert practical experience of continuous manufacturing.

This is an event for members of EIPG member organisations. Contact your national association EIPG representative for further information.