Legislative reforms aligned with current off-patent market conditions are the precondition for a coherent policy to improve the secure supply of essential medicines. The EU structured dialogue on medicines manufacturing is a critical first step to align stakeholders on workable reforms.
As the biggest supplier of prescription medicines, our industry is committed to improving security of supply in Europe.
for security of supply, legislative reform should cover:
Speaking at the EU Structured Dialogue, Medicines for Europe President, Christoph Stoller (TEVA) outlined ““Pharmaceutical and industrial policy, must be an enabler for robust supply chains and support our industry efforts to mitigate and address the root causes of supply chain vulnerabilities, while ultimately supporting more investments in European manufacturing. The urgency is to agree and implement smart regulatory and economic policies! In the off patent sector, the race to the lowest price has reached its limit. And rather than punishing companies via penalties or by implementing distortive national requirements such as stockpiling, we should think win win”.
Medicines for Europe Vice President Rebecca Guntern (Sandoz) said: “We need to jointly design a coherent policy to ensure security of supply for essential medicines, which is better aligned with the prevailing market conditions for off-patent medicines. Medicine manufacturing costs cannot be compressed indefinitely. We need policies that enable a meaningful digital framework, promote flexible regulatory systems and phase out unhelpful and short-sighted cost-containment measures”.
Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
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The newly launched update of the industrial strategy aims to support Europe’s recovery and boost open strategic manufacturing in Europe. With COVID-19 still a threat, Europe’s economic health and global interdependence requires attention. Few sectors could be considered more strategic than healthcare.
Medicines for Europe members supply and manufacture the majority of emergency medicines (70-90% of ICU medicines), anti-infective medicines and chronic care medicines, widely used to treat cancer, cardiac conditions, infectious and respiratory diseases including COVID-19. Essential medicines are produced in over 400 manufacturing sites across Europe. Yet the sector operates under cost-containment policies by member states and has consolidated over time.
While Europe remains a major global manufacturer of active pharmaceutical ingredients (API) and on complex medicine production processes[1], the reality is that India and China are growing their production at a much faster rate. India and China are also pursuing robust industrial strategies to encourage an expansion of medicines production in their territories. The COVID-19 pandemic underlined the critical importance of robust medicines manufacturing capabilities and should encourage the EU to pursue a smart industrial strategy for pharmaceutical production including:
Medicines for Europe President, Christoph Stoller (TEVA) said: “It is painful to see Europe gradually losing its essential pharmaceutical production. This cannot continue. The EU industrial strategy published last week is an important first step to slow this process but tailored actions for the healthcare industry are needed. The EU has set up important initiatives to move in this direction, such as the EU structured dialogue on medicines manufacturing. We need a robust manufacturing policy focusing on critical manufacturing technologies to strengthen EU resilience and deliver equitable access to medicines. but we would like to see this reflected across European Commission directorates. Medicines for Europe will engage constructively to achieve this goal together, supporting the security of supply of medicines.”
Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
[1] European Commission staff working document, page 136
Christoph Stoller will speak at 3A CONFERENCE – Availability, Accessibility, Affordability of Medicines and Medical Devices, organised by the Portuguese Presidency of the European Union at 11.30AM CET.
When I took over the Presidency of Medicines for Europe in 2019, I made sustainable and equitable access to medicines a priority for our sector. I set out to identify key recommendations to protect access to affordable medicines, while supporting a vibrant and strategic medicines manufacturing base in Europe.
As COVID-19 changed our perspectives on EU health policy, these issues are gaining traction and are heavily featured in the in the pharmaceutical strategy.
Off-patent medicines deliver equitable access to medicines. Generic medicines have doubled access for patients with diabetes and cardiac conditions and represent 70-90% of ICU medicines. Biosimilar medicines are drastically increasing access to biological therapies for cancer and auto-immune conditions such as rheumatoid arthritis or psoriasis and value added medicines are increasing patients’ quality of life for chronic diseases and we have seen this in action, as medicine repurposing has been a cornerstone in the response to COVID-19.
COVID19 has been a wakeup call and in my view has demonstrated three key priorities which still require action:
– Christoph Stoller
President, Medicines for Europe (Teva)
Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.
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