Europe is the cradle of the manufacturing industry and has been at the forefront of industrial revolutions and technological innovations. The industry directly employs over 34 million people across all Member States, in supply chains comprising hundreds of thousands of SMEs and larger suppliers. It also indirectly accounts for millions of additional jobs in related sectors.
The European manufacturing industry has tremendous capacity for research and innovation, boasts a skilled workforce and has earned a global reputation for quality and sustainability. What it now needs is the swift and determined support of the European institutions and the Member States to create more jobs and growth in Europe.
The time has come to raise the alarm about the considerable challenges that we are all facing. Between 2000 and 2014, the share of manufacturing in total EU output fell from 18.8% to 15.3%, while 3.5 million manufacturing jobs were lost between 2008 and 2014. Meanwhile, countries around the world are putting industry at the very top of their political agendas. The “Make in India” strategy aims to ensure India is “the next manufacturing destination” and “Made in China 2025” seeks to turn China into the “leading manufacturing power”. The recent US shift towards “America First” will inevitably have a strong impact on their industrial policy.
At the beginning of his mandate, European Commission President Jean-Claude Juncker identified the reindustrialisation of Europe as one of his top priorities and confirmed the objective of increasing the share of industry in the European GDP to 20% by 2020. As we approach the preparation of the next Multiannual Financial Framework, it is vital for the European Commission to act and help the EU remain a competitive global industrial power playing in a fairer world market.
Therefore we, the European manufacturing industry, representing a diverse range of sectors, call on the European Commission to:
Member States and the European Parliament clearly stated their full support for a strong European industrial strategy via the European Council Conclusions calling to strengthen and modernise the EU’s industrial base (15 December 2016) and the Parliament Resolution on the need for a European reindustrialisation policy (5 October 2016).
We, the Signatories of this Joint Declaration, are ready to step up our cooperation with the European Commission, the European Parliament and the Competitiveness Council to define and implement this ambitious and coordinated European industrial strategy that will help safeguard the world leadership of European manufacturers and jobs in Europe.
See the full Joint Declaration for an ambitious EU industrial strategy
Medicines for Europe welcomes the approval by the European Parliament of the EU and Canada Comprehensive Economic and Trade Agreement (CETA) that can be an opportunity for medicine manufacturers in the two regions. The Medicines for Europe trade agenda works to promote access for patients to high quality medicines around the world. The CETA has the potential to strengthen the European manufacturing base of the generic, biosimilar and value added medicines industries, which are investing in existing and new manufacturing plants across Europe.
The CETA includes a Supplementary Protection Certificate (SPC) protection in Canada, which extends market exclusivity for originator industries for regulatory marketing approval delays. It also provides for an SPC manufacturing waiver, which the European Commission is planning to implement in the context of its Single Market Strategy. Once introduced, the SPC manufacturing waiver will create over 60000 new export-related jobs in the generic and biosimilar medicines sector while boosting our capacity to supply cost-competitive medicines in Europe and abroad. Medicines for Europe calls on the European Commission to rapidly seize this historic opportunity to increase manufacturing growth and employment in the pharmaceutical sector by introducing the SPC manufacturing waiver foreseen by the CETA.
“Generic and biosimilar medicines will represent 80% of the volume of medicines by 2020. If Europe wants to keep a strong pharmaceutical manufacturing sector, it needs to adopt the SPC manufacturing waiver now”, commented Adrian van den Hoven, Medicines for Europe Director General.
Today, Medicines for Europe engaged alongside its Irish national association Health Enterprise Alliance (HEA) in illustrating the benefits of stimulating competition in the biologic medicines market in Ireland. Market barriers have unintentionally led to low levels of competition and as a result Ireland has lost out on the benefits of biosimilar medicines. Ireland currently has one of the lowest shares of biosimilar medicines in all of Europe. An effective biosimilar medicines policy should remove the barriers to competition and enable Ireland to leapfrog to the top of the European league.
Adrian van den Hoven, Medicines for Europe Director General, outlined that to unleash the full potential of biosimilar medicines, Ireland needs to remove the barriers to effective competition. Ten years of European experience with biosimilar medicines has proven that biosimilar medicines can massively improve access to medicines while contributing to a sustainable pharmaceutical budget. Sharing the gains of biosimilar medicines competition between patients, physicians and payers (hospitals or the health budget) is a powerful tool to enable access, provide treatment alternatives and deliver tangible results for savings on drugs bills. “Ireland needs to raise its game in biosimilar medicines. EU regulatory agencies and medical societies such as EULAR, ECCO or ESMO are widely supportive of physician-led switching based on the wealth of clinical experience and data available on the 10 years of biosimilar medicines”.
Early adopters of biosimilar medicines such as Germany have seen drastic improvement in patient access to modern therapies, both in terms of the number of patients who can be treated as well as considering them earlier in the treatment cycle where medically appropriate. At the same time they have also provided savings to the health budget and this has enabled policy makers to re-invest into the healthcare system for much needed services and products.
The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists have announced a series of recommendations on the provision of information, designed to help tackle medicines shortages.
Focusing on the transparency and the availability of medicine shortage data, the Associations’ statement is part of their wider commitment to tackling the issue. Evidence suggests it is an increasing problem across the European Union, having a significant impact on patients, on health professionals, on healthcare systems and suppliers.
The recommendations call for greater transparency and availability of medicines shortage data, early detection and assessment of potential shortages, consistency of reporting, increased access to the information available across all parts of the supply chain, improved data infrastructure, and collaborative governance processes.
The recommendations aim to mitigate the impact of shortages on patients, provide patients and health professionals with up-to-date, meaningful information and improve the ability of health systems to diagnose and solve supply issues as they arise.
This statement builds on existing good practices and recommends some specific features of ideal medicines shortages information systems. The European associations representing manufacturers of medicinal products, parallel distributors, pharmaceutical wholesalers and pharmacists hope that, taking into consideration the national specificities of each country, these recommendations can help enhance information systems at a national level, and potentially form the basis of future European level action.
Joint Supply Chain Actors Statement on Information and Medicinal Products Shortages
Today, the Environment, Public Health and Food Safety Committee (ENVI) voted on an initiative report that places generic, biosimilar and value added medicines at the heart of the debate on access to medicines, which is expected to be adopted in Plenary in March. The report underlines that generic medicines are a cornerstone of European healthcare, biosimilar medicines offer tremendous opportunity for access to biotherapies and that value added medicines can help to address major healthcare challenges such as compliance to treatment, polypharmacy or reducing medication errors in hospital.
The report confirms that the EU is serious about improving access to medicines for European patients. Together with the June 2016 Council Conclusions, this report provides the Commission with a clear mandate to encourage more competition from generic and biosimilar medicines and recognises the importance of assessing the worth of value added medicines. This should translate into concrete support measures for Member States to help remove barriers and stimulate uptake – for example in the EU Semester Country Specific Recommendations. “After many debates, the Parliament is aligning with the Council to make competition from generic, biosimilar and value added medicines a high priority in policies to support access to medicines. The Commission should now take action to ensure that these proposals are translated into real measures so that all patients across Europe get the access they need. ” commented Adrian van den Hoven, Medicines for Europe Director General.
MEPs are also calling on the European Commission to stimulate early export of generic and biosimilar medicines to countries where no patent or Supplementary Protection Certificate (SPC) exists. The export of generic and biosimilar medicines to non-EU countries during the SPC period will increase access to high quality medicines in third countries, without changing the equilibrium between the originator and the generic and biosimilar medicines industries in the EU.
This week in London, Medicines for Europe gathers national authorities, regulators and industry leaders to discuss future challenges and opportunities in the regulatory environment of the generic medicines industry. Important topics such as the future model of patient treatment and care, the evolution of generic medicines, the use of modern technology to support patient needs (such as the e-leaflet and mobile apps) and the optimisation of regulatory operations will be discussed during the two-day conference.
The optimisation of regulatory operations, reflected in the HMA/ EMA and CMDh 2020 workplans, are an important milestone for regulators and the industry. The recently created ‘Regulatory Optimisation Group’ (ROG) offers a promising platform to find practical solutions for regulatory efficiency and operational excellence. Industry will support this optimisation process for the benefit of patients and all partners involved in or impacted by regulatory activities. Other topics related to the overview of the globalised pharmaceutical supply chain will be discussed to create synergy between the industry and authorities on ensuring data integrity.
Adrian van den Hoven, Medicines for Europe Director General commented: “This event provides an invaluable platform for all stakeholders to build a 21st century regulatory system that prioritises patient needs, enables regulatory agencies to use their limited resources efficiently and the industry to deliver better access for better health.”
National authorities, regulators, industry leaders and pharmacists gathered in London this week to discuss how to improve patient access to safe medicines with an effective pharmacovigilance policy. This 10th edition of our Medicines for Europe conference highlighted how, if steered appropriately, technology and social media could strengthen the pharmacovigilance system.
Participants also reviewed experience gained in the implementation of EU pharmacovigilance legislation and underlined the need to optimise the use of regulatory and industry resources by applying a risk based approach. The conference called for more efficient distribution of educational material to patients and healthcare professionals. Cooperation between Industry and regulators should ensure that changes to signal detection processes do not lead to unnecessary duplication of work on both sides.
Adrian van den Hoven, Medicines for Europe Director General commented: “10 years of close cooperation between industry and regulators has led to a vastly improved pharmacovigilance system for European patients and healthcare professionals. New IT tools now need to become a big part of our cooperation to build an even better system over the next decade”.
Today, the European Commission published a unique Q&A for patients with reliable information on biosimilar medicines. Stakeholders value these efforts to provide unbiased, scientifically correct and yet easy to understand information on biosimilar medicines through the Q&A on Biosimilar Medicines, now available in 7 EU languages.
This consensus information on biosimilar medicinal products was drafted for patients together with the European Medicines Agency (EMA), the European Commission and relevant stakeholders: the European Patients Forum (EPF), the European Federation of Crohn’s & Ulcerative Colitis Associations (EFCCA), the Standing Committee of European Doctors, European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bio-industries (EuropaBio) and Medicines for Europe.
Biological medicines (including biosimilar medicines) come from living organisms (cells) that have been modified using biotechnology. A biosimilar medicine is developed to be highly similar to an existing biological medicine and has the same biological activity. Biological medicines help treat or prevent many severe diseases including cancers, heart attacks, stroke, diabetes, and autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease. Biosimilar medicines have significant potential to create competition in the biological medicine market and provide broader affordable access to medicines for patients.
For the third year in a row, the European Commission will organise a multi-stakeholder workshop on biosimilar medicines 5 May 2017. This year, the focus will be on developing a Q&A for healthcare professionals.
About the Biosimilar Medicines Group
The Biosimilar Medicines Group is a sector group of Medicines for Europe and represents the leading companies developing, manufacturing and marketing biosimilar medicines across Europe. Our members bring competition to the biologic medicines market, thereby increasing access to highly innovative medical treatments to patients in Europe and around the world, and supporting the sustainability of the European healthcare systems.
For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
Medicines for Europe Communications:
Doris Casares doris@medicinesforeurope.com /Andrea Bedorin abedorin@medicinesforeurope.com
About EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 39 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.
EFPIA Communications Team:
communications@efpia.eu; +32 2626 2555
About EuropaBio
EuropaBio, the European Association for Bioindustries, promotes an innovative and dynamic European biotechnology industry. EuropaBio and its members are committed to the socially responsible use of biotechnology to improve quality of life, to prevent, diagnose, treat and cure diseases, to improve the quality and quantity of food and feedstuffs and to move towards a biobased and zero-waste economy. EuropaBio represents 75 corporate and associate members and bio regions, and 17 national biotechnology associations in turn representing over 1800 biotech SMEs.
Read more about our work at www.europabio.org.
EuropaBio Communications Team:
Cosmin Popa, c.popa@europabio.org, +32 2 739 11 73
Strategic Alliance Made Official Following Successful mid-December Pharma CMO Summit Event in Berlin
Princeton, NJ – Supply Chain Wizard (SCW) – a leading full-service global consulting firm specializing in serialization and traceability, supply chain strategy and operational transformation programs – has officially partnered with Medicines for Europe, which represents the generic, biosimilar and value-added medicines industries across Europe.
Held December 12 in Berlin, the co-hosted Pharma CMO Summit drew more than 100 pharmaceutical executives from 27 countries. The summit was formed to serve as a resource for European pharmaceutical manufacturers moving to incorporate serialization processes to meet approaching regulatory deadlines – 2017 & 2023 for the United States, 2019 for the European Union – the strategic alliance comes on the heels of a highly successful event of the same topic.
With Optel Vision as the main sponsor, additional pharma manufacturer sponsors such as Abbott, Teva, Mylan and Nordic Group, and leading third-party logistics and solution sponsors, the event was well represented by key players in the serialization space. With serialization and track & trace deadlines looming, all parties were eager to obtain valuable insights into the challenges and intricacies facing companies in both Europe and the United States. Key to the event’s success were the networking events that provided ample opportunity to exchange serialization advice and experiences with peers from around the world.
The event also showcased ways in which serialization can go beyond mere regulation compliance to provide opportunities for enhanced business practices through data analytics produced by such systems. In this fashion, regulations once deemed onerous are actually opening doors to smarter manufacturing and supply chain operations.
As for the new partnership between Supply Chain Wizard and Medicines for Europe, the alliance brings together an industry advocacy group with a leading serialization consultant, helping European manufacturers of generic, biosimilar and value-added medicines connect the dots between learning about pending regulations and actually meeting their requirements.
“Education about serialization and track & trace regulations will always be ongoing but, as deadlines approach, it is time to turn informed plans into actualized, real-world solutions,” said Evren Ozkaya, founder and CEO of Supply Chain Wizard.
“As a leading partner for better healthcare, the organization aims to increase the health and well-being of all Europeans, while also addressing the business needs of European pharmaceutical manufacturers,” said Adrian van den Hoven, Director General of Medicines for Europe. “Partnering with a serialization & supply chain expert as well-regarded as Supply Chain Wizard helps us better serve both of these audiences.”
About Supply Chain Wizard
Supply Chain Wizard, LLC, is a leading full-service global consulting firm specializing in serialization and traceability, as well as supply chain strategy and operational transformation programs. Dedicated to optimizing operations for growth, service and efficiency, Supply Chain Wizard offers strategic innovations in products and services targeting serialization and supply chain transformation initiatives, along with a team of expert consultants providing comprehensive support toward cost-effective compliance with serialization mandates and post-go-live operational support.
Supply Chain Wizard organizes serialization roundtables, summits and training programs throughout Europe, Asia Pacific and the United States, and runs frequent webinars to support clients with their regulatory and compliance challenges. Committed to helping clients maintain significant and sustainable performance improvements, Supply Chain Wizard guides customers to a more secure supply chain via the implementation of high return-on-investment initiatives.
Supply Chain Wizard is headquartered in Princeton, NJ, with additional offices in Germany, Netherlands, Turkey and India. For more information, please visit www.supplychainwizard.com.
Medicines for Europe and Pharmexcil today organised a Workshop on Global Pharmaceutical Operations in New Delhi, gathering key authorities, regulators and senior pharma executives from India and Europe for the first time. During the workshop, the conference participants debated on mutual reliance with regard to the effects of globalisation and the interplay of trust, regulation and business; how to create a universally acceptable quality culture in relation to GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) compliance and how to foster regulatory cooperation between the EU and India.
India and Europe are two major centres for pharmaceutical development, clinical development and manufacturing. There are opportunities to strengthen the global competitiveness of these two centres through cooperation. Close cooperation and trust between regulators and industry in both regions can support a positive environment for business cooperation based on mutual reliance. One of the tools through which this trust can be built is through regulatory collaboration and by partnering with stakeholders in the globalised market to ensure full understanding of the requirements of good practice.
Adrian van den Hoven, Medicines for Europe Director General commented: “The globalisation of the pharmaceutical industry operations has fuelled a debate internationally regarding opportunities, challenges related to regulation across the manufacturing supply chain. Medicines for Europe supports regulatory cooperation with our partners to ensure effective and efficient regulation for better access to high quality medicines for patients in India and in Europe”.