Almost 70% of medicines dispensed in Europe are generic medicines
Medicines for Europe and APOGEN have pleasure in announcing today’s Open Industry Day in Portugal which aims to showcase the quality and safety of generic, biosimilar and value added medicines production in Europe and to discuss current and future market challenges.
This initiative is the second Open Industry Day and has been designed by APOGEN, and host Fresenius Kabi. Following a visit to a Fresenius Kabi manufacturing plant, experts gathered for a debate focused on “Driving excellence in Portugal: delivering more and better healthcare in Europe”.
Speakers included Rui Santos Ivo, President of INFARMED, Renata Silva Gomes, AICEP Health Row Specialist, Marc-Alexander Mahl, Medicines for Europe Vice President, Paulo Lilaia, APOGEN’s Vice President and Glenn Luís, Managing Director of Fresenius Kabi Portugal and they discussed the key challenges that off-patent medicines currently face in terms of market and industrial sustainability and explored opportunities for further growth in Portugal and Europe. Among the key thought-leaders at the event were João Neves, Secretary of State for Economy and Rui Santos Ivo representing the Minister of Health.
The debate highlighted the importance of strengthening synergies between the national and European levels on relevant issues such as tackling medicine shortages and improving procurement systems to ensure patient access to medicines.
A forward-looking European generic, biosimilar and value added medicines industry
Speaking at the event, Medicines for Europe Vice President Marc-Alexander Mahl said “our goal today is to provide an insight into the operations of a generic pharmaceutical plant, showing the high standards of safety and quality of off-patent medicines manufacturing, which result in life enhancing and life saving medicines. The Open Industry Day is also an opportunity to illustrate the Medicines for Europe vision, ‘Together for Health’ to institutional representatives of the new EU legislative mandate. The EU needs sustainable health policies including an ambitious
pharmaceutical industrial strategy that delivers equitable and sustainable patient access to medicines. Furthermore, we need a pan European response to the upcoming challenges such as medicines shortages , digitalisation, and antimicrobial resistance.”
Higher life expectancy makes generic and biosimilar medicines even more necessary
According to projections, by 2030, Portugal will have almost 2.5 million elderly people, which will significantly impact NHS expenditure. Generic, biosimilar and value added medicines play a key role in the sustainability of Portugal’s health sector. In the hospital environment alone, 75% of the medicines consumed are off-patent, but only impact 26% of the expenditure.
“Between 2011 and July 2019, generic medicines generated savings for the State and patients of more than 3,639 million euros. Generic and biosimilar medicines play a key role in the development of a sustainable health system which delivers better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients.” said Paulo Lilaia, Vice President of APOGEN.
Medicines for Europe welcomes 5th European Commission Stakeholder event on biosimilar medicines products organised today by the Directorate General for the Internal Market, Industry, Entrepreneurship and SMEs (DG GROW).
The event will discuss the competitive forces driving the European biologics market, how to ensure the sustainability of biosimilar medicines development and manufacturing and how to improve early access* to biosimilar medicines. The event provides an important platform for healthcare stakeholders to shape the future landscape and release the untapped benefits of biosimilar medicines competition. The latest launches of biosimilar medicines have demonstrated that markets are maturing, and that the uptake of biosimilar medicines is increasingly rapid.
The EU is the global leader in the biosimilar medicines space, with over 13 years of patient experience. The learnings are clear: biosimilar medicines deliver access and healthier communities when all actors engage, a long-term vision and ambition is set, there is active preparation, introduction and monitoring. EU countries with successful biosimilar medicines use have proactive policies to improve access to medicines, are actively learning from experience, and are adjusting policies to best fit the situation.
“We are committed to continuously bringing earlier*, broader and sustainable access to biologics through biosimilar medicines. To deliver on our mission of advancing patient access, all stakeholders must commit to working together and sharing experiences on how to remove obstacles – only then will we succeed.” commented Isabell Remus, Chair of the Biosimilar Medicines Group.
*where clinically appropriate
Many European countries are grappling with the efficiency of hospital care, which is facing growing demands from an increasingly elderly population. The optimal use of generic, biosimilar and value added medicines is one major contributor to this efficiency.
A new report by KPMG launched today titled ‘Improving healthcare delivery in hospitals by optimized utilization of medicines’ analyses the financing and procurement of medicines in hospitals in 8 European countries. The report outlines the enablers and barriers for increased use of generic, biosimilar and value added medicines in hospitals, and proposes 9 key ingredients to improve access to medicines in the hospital setting. Recommendations cover switching towards a most economically advantageous procedure (MEAT) criteria, awarding tenders to multiple winners whenever applicable and swiftly reopening tender procedures after the entry of the first multi-source medicine. See more information on the key ingredients here.
Medicines for Europe Director General, Adrian van den Hoven said: ‘Hospitals account for the greatest share of care expenditure in EU health provision and are under pressure to deliver for an increasingly elderly population. This report shows that hospitals are missing a major opportunity to benefit from the optimal use of generic, biosimilar and value added medicines and implementing the 9 recommendations is key.”
Brussels, 30 September 2019 – Amidst discussions on the International Procurement Instrument (IPI) relaunched in Council and the hearings of Commissioners-designate taking place this week, AEGIS Europe, the industry alliance representing more than 20 key industries, today urged the EU to take a stronger stance on reciprocity and other reforms needed in the field of public procurement.
Although the EU public procurement market for goods and services is transparent and open to foreign bidders, third countries are increasingly restricting access to their markets while their companies are winning significant contracts abroad, including in Europe.
“There is a blatant lack of level-playing field for European manufacturers, explained Inès Van Lierde, Chair of AEGIS Europe. European companies face an increasing number of barriers when trying to access third country procurement markets – from discriminating requirements to lack of transparency and precluding procurement procedures. On the other hand, competition within the EU is fierce and increasingly based on strategic underbidding from subsidised State-owned companies and government financing. This situation is not fair and poses a threat to EU jobs and growth in many sectors that play a key role in innovation, growth and the future viability of Europe’s economy.”
Today, AEGIS Europe calls on a more strategic approach to the EU procurement framework and the identification and removal of obstacles that impede a level-playing field between European companies and their competitors from third countries. In particular, actions should be taken to tackle abnormally low tenders, strengthen contract award criteria, address non-compliance with EU rules and standards and further promote provisions related to tenders comprising products originating in third countries.
Furthermore, the European Union should beef up its strategy to remove public procurement-related barriers faced by European companies on international markets. This should especially include an ambitious ‘International Procurement Instrument’ providing real leverage to push third countries to open their markets.
Finally, long-term financing for EU manufacturers under fair and transparent conditions are crucial given that global competition within many industrial sectors is very often driven by access to finance. Therefore, a level-playing field in financing conditions (use of State-supported Export Credits, strengthening of EU long-term financing tools, introduction of due diligence requirements…) must be ensured to stimulate global fair competition. In addition, EU public funding tools should promote projects of real European added value, especially in terms of EU employment, investments and sustainability standards.
Christoph Stoller was elected as President of Medicines for Europe today for a 2 year period.
Christoph is currently General Manager for Teva Germany and Austria, and has taken an active role on the Medicines for Europe Board over the last 5 years.
To mark the launch of his Presidency, Christoph outlined four key priorities for his two year mandate:
Director General of Medicines for Europe, Adrian Van Den Hoven, commented: “With over 25 years of industry experience and a true passion for healthcare, Christoph will continue to drive the industry on sustainable access to medicines for patients. Over the last 10 years our industry has doubled access to medicines for patients with diabetes and cardiac conditions and increased the quality of life for a huge number of patients with chronic conditions. Christoph’s leadership will help our industry accelerate this trend.”
Speaking at the launch of his Presidency, Christoph commented: “With our companies providing 67% of dispensed medicines in Europe, there has never been a more important time for the generic, biosimilar and value added medicines industries to help national health systems address the challenges of sustainability driven by an ageing population, and the increased prevalence of chronic diseases.
The current situation across Europe with regards shortages of essential medicines needs to be tackled. Our industry is ready to partner with governments to rapidly introduce policy reforms to ensure sustainable access to and availability of medicines. I call on the Commission and its newly elected President Ursula von der Leyen together with the designated Commissioner for Health Kyriakides to take action on sustainable access to medicines for patients, by setting up a high level pharmaceutical forum to tackle the challenges in the medicines sector.
I look forward to working with policy makers and stakeholders to strengthen the health and well-being of the citizens who rely on our medicines across Europe.”
Christoph Stoller is a Senior Vice President of Teva and President Medicines for Europe.
In his current role as General Manager for Teva´s cluster Germany & Austria he is responsible for Teva´s Generics, OTC and Specialty Medicines businesses and he is Managing Director of all Teva´s legal entities in Germany. Until June 2017 he served as Chief Operating Officer Global Generic Medicines Europe. As part of that role he also led all activities integrating Actavis Generics into Teva in Europe as Chief Integration Officer Europe. In addition, he was responsible for the negotiations to get the approval of the European Commission and all associated divestment activities.
Christoph has been a member of the Board as well as of the Executive Committee of Medicines for Europe since 2014. Furthermore he has been pivotal in setting up the sector group on Value Added Medicines and has chaired that sector group until 2017.
Christoph has been working for Teva Europe in various roles with increasing responsibility since 2011 after having joined Teva as General Manager in Switzerland in July 2008. Before joining Teva he worked for Zur Rose Group as member of the Executive Board and General Manager Helvepharm, DSM, F. Hoffmann-La Roche and Swiss Re.
Christoph is a Swiss citizen and has a degree in business administration from the University of St. Gallen, Switzerland (lic.oec.HSG).
The value added medicines sector group of Medicines for Europe welcomes the publication from IQVIA’s Thought Leadership “A Digital Future for Value Added Medicines”.
The publication provides valuable insights on the drivers behind the sector, its challenges and what the future holds for value added medicines. The importance of regulatory and payer environments to evolve pragmatically and stimulate the development of this innovation as well as seizing the future digital endeavours are especially insightful.
Adrian van den Hoven, Director General of Medicines for Europe, commented: “IQVIA’s publication shows the future opportunity that value added medicines will bring to patients, healthcare communities and society. The report highlights important global trends and therapy areas that will shape the future of the sector. We encourage governments and the healthcare community to work together to optimise regulatory and reimbursement decision-making processes to take advantage of the opportunity of value added medicines!”
The full report can be accessed here.
Medicines for Europe is ready to engage with the EU to drive the access to medicines agenda in line with the European Council declaration of 20th June on good healthcare access. Our industry supplies close to 70% of prescription medicines and plays a fundamental role in lifting barriers for patient access to therapy. Generic medicines have doubled access to therapy in major chronic diseases over the last 10 years and biosimilar medicines offer a similar hope for patients requiring biological medicines. Value added medicines can empower patients and healthcare practitioners to improve treatment options – especially for chronic care.
To achieve equity of access to medicines, the EU needs focused pharmaceutical policies that stimulate competition in the off-patent medicine market:
Equitable access to medicines should be the mainstay of an efficient, sustainable and cost-effective pharmaceutical policy of the European Union.
Find out more about Medicines for Europe’s policy priorities for the incoming European Institutional mandate, Together for Health here https://www.medicinesforeurope.com/together4health/
Global medicine manufacturers gathered in Warsaw this week to discuss the contribution of the generic, biosimilar and value added medicines to patient access and durable healthcare systems around the world.
Delivering access is at the core of the off patent sector. Generic medicines provide for 67% of dispensed medicines in Europe alone and have doubled access to medicines for patients with diabetes or cardiac conditions.
In an era of growing incidence rates of chronic diseases, global competition, and digitalisation, the sustainability of the industry cannot be left behind if the sector is to continue providing benefits for public health and the sustainability of healthcare systems. Our call is for access-focused pharmaceutical policies, efficient international regulatory cooperation, fostering the use of biosimilar medicines, and facilitating continuous innovation for value added medicines. These are some of the pathways to deliver better healthcare globally.
Medicines for Europe President Marc-Alexander Mahl commented “We are committed to delivering better patient access to medicines. Industry and stakeholders need clear access-focused policies to ensure that the generic, biosimilar and value added medicines can continue delivering on public health. I look forward to working with the newly elected European Parliament and the incoming European Commission to achieve this.”
Jim Keon, Chair of the International Generic and Biosimilar medicines Association (IGBA) commented “Developing international frameworks supporting true global development for generic and biosimilar medicines, a more competitive business environment for the off-patent sector around the globe as well as promoting the implementation of balanced, well-functioning and transparent intellectual property systems in all jurisdictions are essential to support equity of access to healthcare and the UN Member States vision of Universal Health Coverage (UHC) by 2030.”