Industry Report. Global Traceability and Serialisation in Pharma Edition

Transcription

1 Industry Report Global Traceability and Serialisation in Pharma 2015 Edition

2 Contents 3 Introduction 4 Pharmaceutical serialisation and traceability 2015 survey results and sight Research Results Industry perspectives Serialisation deadlines: Printable Worldmap 16 Conclusion

3 SECURING THE SUPPLY CHAIN IS THE TOP PRIORITY FOR THE GLOBAL PHARMACEUTICAL INDUSTRY. Introduction Fake pharmaceuticals have the potential to be harmful for consumption. This possibility was seen back in 2013 when the FDA alerted the industry of the existence of a counterfeit cancer medicine that was distributed in the US. The regulator advised against its use due to concerns that the pharmaceutical may have been unsafe or ineffective. The World Health Organization (WHO) defines a counterfeit medicine as follows: A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging. Experts note that public awareness of counterfeit medicines gathered speed since a discussion on the matter arose at a 1985 WHO Conference. Pfizer notes that recent years have seen a significant rise in the level of counterfeit medicines reaching consumers across Europe through illicit sources such as the internet as patients scout the web to find cheaper offers with an element of convenience. For counterfeit drugs to reach hospitals, a long supply chain only needs a single weakness for a breach to take effect. Serialisation acts as a security measure, enabling accountability and traceability of every pharmaceutical in the supply chain, assuring a level of product safety. However adhering to serialisation s new requirements is not an easy task for all, and presents added costs. Nitin Dahad notes that, theoretically, for firms familiar to cold chain monitoring, the cost of serialisation may not be too significant to collect additional data, however for others, a drastic change in infrastructure may be required. The lack of a worldwide standard in track and trace regulations, with some markets being more established than others, can complicate the reality of being globally compliant. At this point, the pharma market faces waves of oncoming regulation deadlines from different countries. One being the EU Delegated Acts due to be published at the end of this year. In this 2015 Serialisation Report, Pharma IQ presents the findings of its latest industry survey while drawing trends on previous years to explore the shifts in industry consensus. Plus, Pharma IQ presents its printable Serialisation Deadline Worldmap on page 15. I hope you enjoy Chanice Henry Regards Pharma IQ Editor 3

4 Pharmaceutical Serialisation and Traceability 2015 Survey Results and Insight About the Survey Pharma IQ conducted an online survey in June 2015 to assess current industry trends in serialisation implementation and challenges in securing, tracking and managing pharmaceutical products. There are many stakeholders involved in serialisation and the survey gathered the responses of the international pharmaceutical community. Similar to last year s survey, the 2015 survey focuses primarily on the end-user perspective, with the majority of respondents sitting in the supply chain and packaging functions at pharmaceutical and biotech companies. However, this survey looks at December s approaching delegated acts and the positioning of the market as it stands now. We also chart the industry s progress through trend analysis with our previous Pharmaceutical Serialisation Survey s in Time is Running Out: Are You Ready For Serialisation? and 2014 s Industry Report: Global Traceability and Serialisation in Pharma. What profile company are you from? Which function do you sit in? % 30.9% 1.8% 1.8% 43.6% Large pharma/bio manufacturer Small-to-mid-sized pharma/bio manufacturer Medical device manufacturer Government Other Other Includes: Inspection system manufacturer Combating counterfeit products Software supplier Pharmacist Wholesale distribution 24.4% 22.2% 15.6% 13.3% 11.1% 11.1% 2.2% 26.2% Supply Chain Packaging Manufacturing IT Quality Compliance Regulatory Affairs Procurement Other Other Includes: Business development manager Legal advisor Continuous improvement & technology Sales

5 2015 Research Results 2015 My organisation has a clear and robust roadmap for serialisation / track and trace globally? Strongly Agree 40% Agree 33% Disagree 25% Strongly Disagree 2% 2014 My organisation has a clear and robust roadmap for serialisation / track and trace globally? Strongly Agree 27% Agree 38% Disagree 23% Strongly Disagree 12% 5 Undoubtedly the majority of 2015 s participants, just over 70%, feel that their firms hold a clear plan for serialisation on a global scale. This is a 7% increase in comparison to last year s participants.

6 2015 Research Results 2015 My organisation... Has not started thinking about serialisation yet 15% Is in early planning phases 15% Is currently looking for solution providers to partner with 19% Has started rollout in one site (pilot) 19% Has started rollout across multiple sites globally 21% Has fully implemented 11% 2014 My organisation... Has not started thinking about serialisation yet Is in early planning phases 18% Is currently looking for solution providers to partner with 8% Has chosen partners, awaiting implementation 6% Has started rollout in one site (pilot) 15% Has started rollout across multiple sites globally 27% 26% 2012 My organisation... Has not started thinking about serialisation yet 7% Is in early planning phases 13% Is currently looking for solution providers to partner with Has started rollout in one site (pilot) 13% Has started rollout across multiple sites globally 19% 48% Prior to conducting this survey we asked Bill Fletcher Managing Partner of Pharma Logic Solutions for his forecast on the most likely outcome for this question. 6 BIll Fletcher - I think the majority have already started their projects. The directive has been around for many, many years, there are requirements in several other countries that have compelled companies to move forward. I would say, probably in the order of a very, very high percentage has already started, already got the project underway. I don t know that there s a lot of value in guessing it but it would be greater than 75%

7 2015 Research Results How long do you anticipate it will be until you are fully serialised? % 2% 12% 17% 21% 33% Already fully serialised <6 months 6-12 months months months >24 months % 24% 38% 4% 6% 23% Already fully serialised <6 months 6-12 months months months >24 months Just under 15% of 2015 s respondents state they are fully serialised, which is a jump from last year of which only 3 percent of respondents felt their corporations were fully serialised. The majority of respondents this year feel they will need at least 24 months before they are fully serialised, whereas in 2014 the participants predicted they would only need 6-12 months. 7

8 2015 Research Results How many packaging lines will you need to upgrade in response to serialisation? 44% 27% 30% 18% 17% 16% 15% 11% 9% 7% 4% 11% 2% < > 100 Don t know Similar to last year s respondents, except for those who are unaware, the majority of participants have confidence that they only need to upgrade less than 10 packaging lines in response to serialisation. What is the main operation challenge you face/will face in implementation? Creation of unique serialisation codes for individual products during the production process Generating high-speed printing and verification of the codes Cross-site coordination for serial generation for similar product lines Integration with enterprise systems Optimum utilisation of existing technologies / machineries 11% 7% 7% 50% 25% % 18% 11% 20% 36% 8 Half of the 2015 respondents highlight intergration with enterprise systems as the largest operation challenge they face. Whereas in 2014 optimum utlisation of existing technologies was a larger problem.

9 2015 Research Results In your opinion what is the greatest concern facing manufacturers in implementing serialisation? We asked all participants what the greatest concern facing manufacturers in implementing serialisation was. The respondents included, large, medium and small pharma firms and bio manufacturers as well as medical device manufacturers. Technological solutions Finding a solution that is highly scalable, secure, and offers track and trace functionalities all in one Slowness Delayed production due to the use of systems based on the minimum size of products Integration with enterprise system Data storing, return handling, organisation when errors show up Understanding of the technologies involved, integration between ERP systems and Enterprise integrators and training Slowness to react and plan ahead Afraid of change Regulation clarity and awareness Regulations are not clear and not yet totally defined Cost Not enough resources. This is a very complicated project due to multiple vendors needed to install all aspects Moving targets, several countries are not really sure how and when to make serialisation mandatory Awareness of timelines for implementation Diversity of standards for different countries Overall cost of implementing the technology for smaller manufacturers Lack of clarity in future legislative requirements and having a future-proof solution Logistics Standardization across all sites and integration with trading partners Impact on logistic processes and the size of database generated when using aggregation, required for China and other countries Quality management 9 Lack of CMO preparedness

10 2015 Research Results Have you started forecasting and implementing changes in regards to potential outcomes for the EU delegated acts? Yes- we are forecasting but are have not implemented 18% We plan to start forecasting and implementing in the near future 64% Yes- We have forecasted and are starting to implement. 18% In preparation for the serialisation deadlines, my company is at the following stage for the below technologies: Printers and other line level equipment Data management /software Preparation Cartoners or additional handling equipment Manufacturing Execution System (MES) ERP system (e.g. SAP, Oracle, etc.) Barcode readers/ scanners Consultancy services Implementation complete Vendor selection complete Started Initial research Don t Know Implementation under way Vendor selection initiated Not started Initial research 10 Barcode readers / scanners seems to be the area that is the most complete within 2015 s respondents, an increase on last year. Consultancy services is an area which is lacking in progress, this seems to have reduced in comparison to last year s results.

11 Research Results Approximately what sort of budget size will need to be invested in the solutions above? % 10% 15% 10% 0% 45% 100, , ,000-1,000,000 1,000,000-10,000,000 10,000, ,000,000 1,000,000,000+ Don t know % 35% 17% 7% 5% 0% 100, , ,000-1,000,000 1,000,000-10,000,000 10,000, ,000,000 1,000,000,000+ Don t know % 15% 31% 23% 8% 0% 100, , ,000-1,000,000 1,000,000-10,000,000 10,000, ,000,000 1,000,000,000+ Don t know

12 12 Industry perspectives Confusion still present in the serialisation market Pharma IQ speaks to William Fletcher, Managing Partner of Pharma Logic solutions in regards to the serialisation market as it stands today. What are some of the main challenges and concerns faced with implementing serialisation? The challenges are ensuring that the requirements are aligned with the specific company operations. All too often companies turn to solution providers to actually provide a set of requirements and those requirements usually favour the specific solution and then during implementation they find out that they have to make substantial changes to their operations, which can be costly in many ways, including retraining, development of new SOPs, the added risk associated with making change and so on. Other issues that often come up are a loss of continuity in the project where stakeholders move in and out of the project and core information is lost as core members move out and as new members move in they have different understandings of what is required and often that creates a frequent change in the overall direction or strategy. To counteract those I found that it s effective to clearly define the requirements in advance based on what the company needs are and develop a strategy and a roadmap and a charter so that everyone has a consistent understanding of the direction of the project. Do you have any predictions for the possible outcomes on the EU delegated acts? I fully expect that to happen. They ve been in the works for many, many years. I really don t anticipate any issues with that. The delegated acts are simply a set of rules that provide additional details on top of the directive. The directive has been clearly understood for many, many years and I think that people are assuming that the delegated acts will somehow alter or change the directive, which they cannot. So I really don t anticipate too much turmoil. I think that the more specific the delegated acts the easier the implementation will be for everyone. Delegated acts often tend to be somewhat vague and they result in further need for the industry to define in greater detail recommended methods for implementing the directive. Your thoughts on market consensus on serialisation requirements. I think, most companies have a fair understanding of what s required. But, I think you ll find, there s still some confusion. Last week, I was on a conference call to one of my clients and there was a gentleman from the packaging organisation that was under the impression that there is no definition for how a package should be labelled for serialisation, either in the EU or in the US, and of course for both it s fairly well established what s required on the packaging in Europe as well as in the United States. So there are still people that are a little bit confused about the regulations.

13 Industry perspectives Making the business case for implementing serialisation cost-effectively Nitin Dahad of TechSpark Ltd 13 As part of the implementation of serialisation, automation of the process will become law within 10 years. As already highlighted previously, serialisation provides accountability and traceability of every item shipped in the supply chain. The need to conform to these new requirements might at first glance look like it would require costly additional investment. But it need not be and it might even be more cost-effective, once you take into account the additional benefits that could be obtained. The ultimate goal is to provide complete traceability of a product to make companies accountable, and help ensure that medicines being delivered to the patient are safe to use. So the key is to collect information about products through the supply chain. For some companies, cold chain monitoring is already in place in some form, providing temperature data; so collection of additional data should be a simple incremental cost. For others, this may be a completely new area to address, and an investment in technology infrastructure might be required. In both circumstances, the additional information provides much more value that just simply providing serialisation data and this is the key to a demonstrating that a strong return on investment is possible. The additional benefits might include, for example, stronger marketing value (to assure patients that products are safe), improved brand value, and also a more efficient network. So what about the technology infrastructure requirement? Well, that is easy to address. The availability of ubiquitous mobile connectivity and cloud (internet) based data storage capability has made the task of collecting and storing information much easier than ever before. Many vendors now offer cold chain monitoring and track and trace facilities in what is called software-as-a-service (SaaS), or the entire solution platform-as-a-service (PaaS). So there s no need to invest in technology infrastructure as it s already there, and all you have to do is subscribe to a service offering what you need, often on a monthly subscription basis based on various parameters such as the number of points you need to measure. The data gathered gives companies insights into a lot more than just serialisation information it can provide complete logistics details through the whole journey of a particular product. Everything is recorded. This means that people running the logistics network can better understand their supply chain and this data might help them to make improvements and run more efficient supply chain networks. It can also help logistics managers use this data to manage shipping schedules and ultimately boost the bottom line. To use an analogy, consider how web sites like Amazon now provide information to their customers: many now provide a complete track and trace facility for order shipments, so that customers can know at any time where their goods are located on their journey. Now consider this same system implemented in a pharmaceutical temperature-controlled supply chain, with temperature sensors added to the network or along with the shipment. It is possible to both pinpoint exactly where the shipment is at any time, and also overlay a temperature graph on top so that you get a complete picture of the shipment s journey and the temperature history. If this is integrated into existing enterprise systems or workflows, the software technology solution can then provide insights into a complete transport fleet or network of warehouses. And because the data is available live, alerts or warnings can also be sent by or text to responsible persons that a digression or some other problem has occurred during the shipment s journey. From a serialisation point of view, this addresses all necessary requirements: Product identification Product tracing Product verification Detection and response Notification With details on where every box has been, the temperature, and other key parameters, this provides a complete story of the product shipment and helps assure patients that products they receive are safe, and in the process helps add value to your brand and marketing. So when thinking about the justification for the cost of implementing serialisation, it s worth remembering the additional non-measurable benefits that can be achieved and potentially also being able to improve your supply chain efficiency in the process.

14 14 Industry perspectives Stepping Up to the Challenge: Serialisation and Contract Manufacturing Hussein Al-Qasim, Head of Serialisation and Tamper Evidence, Genericon Pharma In this interview Hussein Al-Qasim, Head of Serialisation and Tamper Evidence, Genericon Pharma, speaks to Andrea Charles from Pharma IQ about the specific issues surrounding serialisation strategy that will affect contract manufacturing organisations (CMOs) and shares his thoughts on the future serialisation in the MENA region. Pharma IQ: With the global pharmaceutical contract manufacturing market on the rise, what are the specific issues around serialisation strategy that will affect CMOs? Hussein Al-Qasim: That s a good question. When you talk about effects, you have a lot of aspects to think about here, mainly artwork, IT solutions, tamper evident solutions, the printing itself and talking to different CMOs. In my case, I have different contract manufacturers, so that is also another problem, and with that I will lose the corporate identity, since I have ten to fifteen different contract manufacturers, and the product won t look the same. So I am trying to standardise all my contract manufacturers to what we need. These are just some of the issues, probably the hardest thing here is the cost implementation, the cost of the project. Pharma IQ: Do you think contract manufacturers have enough awareness of the current serialisation landscape? Hussein Al-Qasim: Definitely not. They are becoming more aware, but it is a very slow, gradual rise. Pharma IQ: How is Genericon Pharma seeking to overcome the challenges that you face? Hussein Al-Qasim: Work ahead, plan ahead with every project. You have to work ahead to try to lower the costs of implementation, because if you don t do so, and the time comes for the deadline, you will probably lose some of your product, and that s a lot of loss. Pharma IQ: In your opinion, what s next for the MENA region with respect to serialisation, and what can we expect in the future? Hussein Al-Qasim: Saudi Arabia has already started on this, but they re changing their regulations on a weekly to monthly basis, so we cannot really know what they are planning to do. I think in the future, maybe even beginning of 2020, we will have a serialised system in Saudi Arabia and GCC countries. I don t know how Jordan will do it, but I think they will follow along as well. The other countries, probably not. Pharma IQ: Why do you feel it s important to come and speak at events like IQPC s Pharmaceutical Serialisation and Traceability? Hussein Al-Qasim: Most of our vendors are here. I want them to know what problems we are facing. Another good aspect of it is that you ll meet new vendors that will give you other ideas, you will meet other CMs and CMOs that will also give you new ideas. It s always a benefit to meet different people that have a different background, and through that you can learn new aspects, and how they are dealing with this problem.

15 Serialisation Deadlines: Printable Worldmap As the serialisation industry prepares for various approaching deadlines all over the globe, Pharma IQ has created a printable map to assist with your worldwide compliance efforts. Mexico Jan 2018 Operational database enactment for Draft Mexico Regulation Amendment for general law of health. Argentina 2015 December Delegated acts are to be published. Late EU FMD Safety features compliance expected to come into force. EU 2015 December Delegated acts are to be published. Late EU FMD Safety features compliance expected to come into force. Russia 2015 Supplemental requirements 15 USA 31st Dec California - California Board of Pharmacy (CBoP) Deadline - Manufacturer s Declaration of a 100% formula and compliance method. 31st July CBoP Wholesalers and re-packagers must have accepted and passed pedigrees by July 2019 A declaration of non compliant drug product by manufacturers, wholesaler and re-packagers. 31st July USA pharmacies and pharmacy warehouses must accept pedigrees by July 2017 Declaration of non compliant drug product by manufacturers, wholesalers, re-packagers due. November - USA Drug Supply Chain Security Act (DSCSA) 4 years post enactment, drugs must be serialised by manufacturers at the saleable unit and case level. Re-packager deadlines are beginning Jordan and Libya Jan 2017 Expected deadline for unit level serialisation Saudi Arabia 12 Mar Serialisation Phase 2 - All drugs need to be serialised and contain a 2-d barcode Brazil 10th Dec Phase 1 deadline - Serialisation and tracking data for 3 batches of product ANVISA. 10th Dec Phase 2 deadline - Serialisation and tracking for all pharmaceuticals ANVISA. China Dec 31st All drug products will need to be serialised for both domestic and imported medicines. Taiwan Jan All prescription drugs medication barcode requirements and implementation timelines Korea Jan All pharmaceutical products need to be serialised. Ukraine Feb Serialisation Sales Implementation Phase 1 due for Manufacturers and wholesale distributors.

16 Conclusion Even through pharmaceutical firms seem to be experiencing growing pains as they evolve to new requirements, the tall task of serialisation is one that seems to be within reach for most. Witha large number of firms underway with implementing necessary changes and a strong majority of research respondents feeling their firm has a strong roadmap for serialisation. However, minor industry confusion remains in certain corners of the market, which is not helped by the lack of cohesion between countries on regulation levels with one survey member noting the unhelpfulness of moving targets. Also, some research participants predict that the publishing of the EU Delegated Acts will once again be delayed. However once they are revealed experts believe that they will have a strong influence on global harmonization and help tighten up loop-holes. Acknowledgements Pharma IQ would like to thank all the speakers and delegates at our events, and the members of the Pharma IQ community. This report would not have been possible without the input and views from a significant number of serialisation and traceability participants and stakeholders. There are too many to mention them all but everyone who has taken the time to contribute to our websites or to our events has shared their expertise and experiences in the storage and distribution of temperature sensitive pharmaceuticals. That being said a special thank you to those whom we have directly cited: An especially big thank you is due to the pharmaceutical professionals who took part in our Global Pharmaceutical Serialisation & Traceability 2014 Survey 16

17 04-05 November, 2015 Switzerland As serialisation regulations are pending in the EU, it is imperative to ensure a successful and compliant serialisation strategy for your company. Are you ready to execute your serialisation strategy? Pharma IQ s 6th annual Pharmaceutical Serialisation and Traceability Summit is the only event you need to ensure you are globally and compliantly Serialised. Don t just take our word for it; here is what our delegates from November 2014 have said. I have been to a number of meetings on Serialisation and for me, Pharma IQ s event was by far the best and most udeful. I felt every session was useful, had a really good mix of case studies who could demonstrate real life examples of implementation and challenges thereafter and I only wish I had brought more of my colleagues with me. Servier The 2015 Summit will bring you everything you need to ensure successful and compliant implementation for your serialisation strategy including: Local and global compliance: regulatory updates from the EU, Brazil, China, Saudi Arabia, Korea, Argentina and more including interactive sessions Preparing for the release of the Final Delegated Act Roadmap to serialisation - proven methods to implementing your strategy Successful case studies from leaders in the industry The event was extremely interesting and valuable. Good variety of speakers who provided excellent information on all aspects of the Serialisation/T&T topic and Pasi kept things moving really well. This is one of the best conferences I ve attended in many years. Really good networking opportunities too. Teva Phone: +44(0) enquire@iqpc.co.uk

18 18 About Pharma IQ Pharma IQ, a division of IQPC, is an international online community focusing on providing pharmaceutical professionals with knowledge, information and articles. We are dedicated to creating a learning environment for sharing ideas, best practices and solutions within the pharmaceutical community Through Pharma IQ, you will be able to access pharmaceutical information resources such as presentations and podcasts, as well as events such as webinars, seminars and conferences. By signing up to the Pharma IQ membership, you will gain access to our growing database of multimedia presentations from leading pharma practitioners, weekly newsletters to keep you updated on latest pharmaceutical content and Pharma IQ members-exclusive discounts on pharma events that offer solutions to your everyday business problems. Pharma IQ and IQPC provide useful training courses, conference and expositions for pharmaceutical executives to network and learn the latest pharma business development and trends occurring in organizations today. Pharma IQ focuses on establishing an interactive experience featuring practical, objective and up-to-date insight from pharma industry leaders. Join today for free! Interested in Finding out More? New Look, New Format, New Ideas - Sign up Today at The ideas presented in this report will be discussed in further detail at our Global Series of pharmaceutical and biotech events. Hear from leading experts as to how they are successfully finding strategies for success in pharmaceuticals. To find our more or to sign up for an event, visit or contact our customer services team on customerservice@pharma-iq.com Resources Source: NNEpharmaplan