Today, the European Parliament voted on the report on ‘Options for improving access to medicines’ that places generic, biosimilar and value added medicines at the heart of the debate on access to medicines. Together with the June 2016 Council Conclusions, this report provides the Commission and the Member States with a clear mandate to encourage more competition from generic and biosimilar medicines, underlining that generic medicines are a cornerstone of European healthcare, and biosimilar medicines offer tremendous opportunity for access to biotherapies.
The report also recognises the innovation in the off-patent sector as it can be beneficial for patients and deliver added value (hence value added medicines). These types of medicines will help address major healthcare challenges such as delivering better adherence and quality of life as well as better safety and efficacy and their benefits should be assessed.
“We urge the Commission and Member States to take action to ensure that these proposals are translated into real support measures for generic, biosimilar and value added medicines, allowing all patients across Europe to get access to the treatment they need” commented Adrian van den Hoven, Medicines for Europe Director General.
MEPs are also reiterating the call on the European Commission to stimulate manufacturing and export of generic and biosimilar medicines to countries where no patent or Supplementary Protection Certificate (SPC) exists. A manufacturing waiver for generic and biosimilar medicines during the SPC period will increase access to high quality medicines in unprotected markets, without changing the equilibrium between the originator and the generic and biosimilar medicines industries in the EU.
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
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”.
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”.
Medicines for Europe assessed the publication of the report ‘Health at a Glance 2016’ launched yesterday prepared by the OECD for the European Commission. The report acknowledges that the development of generic medicines markets increases efficiency in pharmaceutical spending, however it focusses on short term cost-containment rather than taking into account access to medicines and the long-term sustainability of healthcare. Generic cost-containment policies have had no significant impact on overall healthcare budgets as the expenditure for generic medicines is only 2-3%. On the other hand, as underlined by the German Pharma Dialogue, cost-containment measures such as tendering significantly increase the risk of medicines shortages that ultimately undermine patient health. The most extreme examples of medicines shortages in Europe are found in countries with unsustainable pharmaceutical pricing policies such as Romania, where the combination of external reference pricing, price linkage and clawback have led to the withdrawal of 2000 medicines and chronic shortages of inexpensive medicines.
Regrettably, the OECD report does not underline the importance of timely availability of generics and biosimilar medicines in order to facilitate patient access to pharmaceutical therapies and to improve the sustainability of national health systems , which would be in line with the Council conclusions and the ‘Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability’. Aside from financially incentivising prescribers, pharmacists and patients, policies should be put in place to reduce time to market and to educate the population on the quality, safety and efficacy of generic medicines and their equivalence to originator medicines. Furthermore, it is important to emphasise the relevance of putting in place key policy measures to increase the use of biosimilar medicines which play a key role in increasing patient access and in the long-term sustainability of healthcare systems.
Adrian van den Hoven, Medicines for Europe Director General commented: “The State of Health in the EU cycle is an important platform to support health policies in EU countries. We encourage the Commission to focus on generic, biosimilar and value-added medicine policies that increase access to medicines for patients rather than short term and counterproductive cost containment measures. Our medicines are developed and manufactured to serve patient needs not austerity policies”.
The statistics are truly disturbing, with an annual death toll of around 100,000 from falsified and counterfeit medicines, according to the European Commission, and a criminal enterprise that the World Customs Organisation estimates could generate £1bn worth of illicit business in 2017.
But industry and regulatory authorities are fighting back with new measures to identify rogue shipments and coordinated action to disrupt the supply lines that criss-cross the globe.
The trend to seek medical aid online has made it easy for bogus medicines – containing anything from paint and antifreeze to brick dust and floor wax – to be mailed around the world. The Alliance for Safe Online Pharmacy in the EU (ASOP EU) warns that 130 million people in Europe are risking their health by ordering from the 30,000 illegal pharmacy websites that have flooded the Internet.