The European Commission has identified the use of generic and biosimilar medicines as crucial for EU health systems in a report released today.
Detailing the potential benefits of generic and biosimilar medicines use, the European Commission identified the urgency to foster the use of biosimilar medicines specifically, an urgency heightened due to the expenditure rate on biological medicines.
Of concern in the report findings were the fluctuations of generic and biosimilar medicines use across EU member states, even though greater competition has a known track record in improving access to safe and effective medicines in health systems across Europe.
Generic and biosimilar medicines were also identified as cornerstones of appropriate use of medicines in the hospital setting. While trends show that hospital pharmaceutical spending is increasing, the benefits of generic and biosimilar medicines use are vital to ensure efficient care.
Speaking on the findings of the report, Medicines for Europe Director General, Adrian van den Hoven commented “The launch of the 2019 State of Health in the EU report reinforces the opportunities brought by generic and biosimilar medicines to improve equitable and sustainable access. We see all over Europe that health systems are struggling to deliver efficient care, while pharmaceutical budgets continue to spiral. Our hope is that EU and national policies seize these opportunities and develop better policies to ensure generic and biosimilar medicines use. This ultimately will enhance the functioning of health systems in Europe and deliver on patient access.”
Value added medicines deliver sustainable and continuous innovation with existing molecules and enhance patients’ well-being.
The 3rd Value Added Medicines Conference brought together thought leaders to discuss the future of digital delivery and the regulatory and market access framework for value added medicines, to help tackle chronic diseases and an ageing population
According to IQVIA, value added medicines have grown 1% in volume in the EU over the last year[1],[2], and many more initiatives are needed for improving patients’ access to value added medicines. During the conference, a multi-stakeholder exchange of ideas identified clear next steps to improve patients’ access to value added medicines:
Speaking at the conference, the Chair of the Value Added Medicines Sector Group at Medicines for Europe, Arun Narayan, commented “The number of people over 80 will double by 2050, rising from 4.7% to 11.3% across 27 EU members[3]. Governments will be more challenged to deliver high-quality care due to rising demand and the physical and mental challenges associated with ageing and value added medicines provide one solution. Within 18 months of the introduction of a pricing and reimbursement legislation in Belgium that supports value added medicines, more Belgian patients are benefiting from safer and more convenient value added medicines. We urge EU governments to adopt the Belgian approach and seize the benefits of continuous improvements to transform health care”
Medicines for Europe President, Christoph Stoller, added “Patients must sit at the heart of the digital health revolution. There are clear and significant benefits to be gained. We have discussed the opportunities ahead – how to make the most of the digital health revolution so that patients can be the ultimate beneficiaries from such continuous innovation. Our ambition as value added medicines manufacturers is to contribute to a healthier society bringing tailored solutions to patients, healthcare professionals and healthcare systems. Today’s conference is a crucial milestone in creating the right environment for value added medicines in Europe.”
The Value Added Medicines sector group instituted two awards for projects that bring value added solutions to patients. The winners of the 2019 awards were:
Winner category ‘Initiatives/campaigns that aim to improve patients’ quality of life and/or adherence and/or demonstrate relevant value added benefits on existing treatments’:
Project ‘Psoplus, A Patient-Centred Consultation Programme For Patients With Psoriasis’, Elfie Deprez
Winner category ‘Scientific research/projects led by academics/healthcare professionals/developers that aim to improve existing treatment adherence and/or convenience and/or patients’ preferences and/or demonstrate relevant value added benefits for patients.’
Project ‘MASK digital anamorphosis: Digital transformation of health and care in airway diseases from research to practice and value added medicines’, Prof Dr Jean Bousquet
[1] IQVIA. Midas database. 2019.
[2] Prescription market
[3] https://www.oecd-ilibrary.org/social-issues-migration-health/ageing_9789264242654-en
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.
