Christoph Stoller, the President of Medicines for Europe, led an important mission to Bulgaria to improve access to medicines in partnership with the Bulgarian Generic Pharmaceutical Association chaired by Nikolay Hadjidontchev. Bulgaria has limited public funding for medicines and patients face the highest drug co-payment costs in all of Europe according to the State of Health in the EU report. To address this challenge, Medicines for Europe met with the Bulgarian minister of Health Kiril Ananiev and with the Chair of the Health Committee of the Bulgarian National Assembly Dr. Daniela Daritkova on 10 December in Sofia. During the exchange, our President underlined how EU pharmaceutical policy under the new Commission should help Bulgarian patients.
Regarding shortages and availability, Medicines for Europe warned that Bulgaria should not apply clawback taxes to generic and biosimilar medicines which are the main driver of access in the system through lower prices for both the national health fund and patient co-payments. He underlined that similar measures in Romania led to 3000 medicine withdrawals and major availability problems as was highlighted by the European Commission (citation DG ECFIN). Recent EU documents such as the Euripid guidance document also advise countries not to apply external reference pricing to generic medicines as this leads to a double price cut (first a reduction of the originator reference price, then a reduction of the legally lower generic medicine price), therefore Bulgaria should prioritise measures such as rational prescribing to ensure greater volume usage of generic medicines to increase access and ensure the stability of the national health fund. Finally, the President made a strong case for a dynamic biosimilar medicines policy. Bulgaria has very low levels of access to biological therapies (3rd lowest in the EU) – including to important cancer and immune therapies. By encouraging uptake of biosimilar medicines through competitive procurement in hospitals and benefit sharing measures for physicians and patients for medicines dispensed in a retail setting, Bulgaria could dramatically increase access to essential biosimilar medicines for Bulgarian patients.
Christoph Stoller said: Medicines for Europe will be a partner for the Bulgarian government to play an active role in EU pharmaceutical policy and to implement strong generic and biosimilar medicines policies as recommended by the European Commission and OECD in the State of Health in the EU report. Together, we can improve access to medicines for all Bulgarians through stepwise improvements to pharmaceutical policy at EU and national level. Our industry is committed to deliver on equity of access to medicines and calls on the Commission to provide technical support to Bulgaria to help it achieve real progress for public health.
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.”
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.