Medicines for Europe warns strongly against energy rationing for medicines production

In line with today European Commission’s Guidelines on a European Gas Demand Reduction Plan, Medicines for Europe urges Governments to maintain energy supply to medicines production sites in the event of energy restrictions in Europe.

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The Supplementary Protection Certificate (SPC) manufacturing waiver becomes operational!

Today the transitional period for the application of the Supplementary Protection Certificate (SPC) manufacturing waiver ends. The SPC manufacturing waiver will become operational and generic and biosimilar medicines companies will be able to start manufacturing in Europe for export, stockpiling, and day 1 launch in Europe.

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The off-patent medicines industry is a vital part of the solution for healthcare resilience

Health systems face tremendous challenges across Europe. The management of COVID-19, war in Ukraine and high inflation rates are challenging supply chains for the most essential medicines.
Off patent medicines account for 70% of those dispensed in Europe, treating severe conditions such as cancer, auto-immune conditions, respiratory diseases, and cardiovascular disease. These medicines are clearly part of the solution for resilient health systems.

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Smart reform of EU pharma and IP legislation key to boosting access to essential medicines

Generic and biosimilar medicines lower healthcare treatment costs dramatically and are essential for enabling access to medicines. The EU has therefore made the prompt launch of generic and biosimilar medicines a high priority objective of the Pharmaceutical Strategy for Europe. The 2022 Medicines for Europe Legal Affairs
Conference debated the much-needed reforms to ensure timely access to medicines.

 

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EPSCO (Health) Council – Open letter from Medicines for Europe Executive Committee to European Health Ministers and responsible European Commissioners on inflation impacting the supply of essential medicines

EU can do more for patients with smart use of biosimilar medicines

Central & Eastern European patients have inequitable access to medicines for life-threatening conditions

Repurposing: a golden opportunity for patient centric health investment in Europe

Report shows the future of meeting unmet medical needs relies on developing tailored EU pathways for value added medicines

Widely researched and resourced during the early stages of the COVID-19 pandemic, repurposing has shown its worth in an emergency. Facilitating repurposing beyond the pandemic promises sustainable developments and patient centric health outcomes in a range of therapy areas.

The upcoming EU pharmaceutical legislation revision is the opportunity to recognise and support the concept of Value Added Medicines, including repurposed medicines and, in doing so, to recognise the potential for Europe.

To make medicine repurposing a success we need to employ all resources at hand to connect different actors. One such connection which can uniquely be addressed by the EU is to assist academia and non-commercial stakeholders in conducting research, as well as facilitating their partnering with the industry in making repurposed medicines available to patients.

The early involvement of industry in repurposing projects opens a range of opportunities like new indications, different/adjusted delivery forms, changing dosage and combining different therapies to meet the needs of the patient community and to bring to market new treatment options in an accessible and affordable way.

The legislative framework must also foresee proportionate incentives, such as 4 years of data exclusivity and a dedicated regulatory route, which, in combination with a fit-for-purpose evaluation framework to assess the benefits, would enable Value Added Medicines (including repurposed medicines) to benefit patients in Europe. These are essential steps in recognising the investment and resources that need to be dedicated to developing a medicine based on a well-known substance.

The Chair of the Value Added Medicines Sector Group at Medicines for Europe, Arun Narayan (Viatris) commented “One of the very few solutions available to manage the early stages of the COVID-19 pandemic was to deploy wide ranging repurposing of known medicines, for those who were critically ill. While we found promising options during that emergency, there is no reason not to support this type of innovation for all disease areas. The EU significantly lags behind other regions of the world, notably the US, in supporting value added medicines with a dedicated regulatory pathway and appropriate incentives. My hope is to see this addressed in the upcoming revision of the EU pharmaceutical legislation so our industry’s capabilities may be dedicated to bringing these solutions to patients.”

Resource hub

Report – Advancing medicines repurposing in the EU, March 2022, available here.

Medicines for Europe Communications:

Kate O’Regan koregan@medicinesforeurope.com

About the Value Added Medicines Group

The Value Added Medicines Group is a sector group of Medicines for Europe which aims at optimizing, rethinking and reinventing medicines based on known molecules and by bringing untapped innovation to improve care delivery. The Value Added Medicines Group adopts a complementary perspective compared to the other Medicines for Europe sector groups: by tackling the targeted portion of patients’ needs that remain unmet to this day, delivering additional improvement to the healthcare community as a whole.

About Medicines for Europe

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.

Call on EU leaders to safeguard access to medicines and build resilience in response to Russia-Ukraine war

The supply of medicines is critical yet unstable as war continues in Ukraine.

As a key medicines supplier, our sector is doing everything possible to support Ukrainians and welcomes the recent establishment of a more coordinated EU approach to the donation of medicines to Ukraine. We are also mobilising our logistical capabilities in close coordination with EU civil protection agencies, the Ukrainian Ministry of Health and NGOs supporting Ukrainian patients in this time of need.

Given the essential role of medicines in humanitarian situations and public health, special effort and protection is needed from European Heads of State and Government.  As EU leaders meet in Brussels to discuss the evolving response to the conflict in Ukraine, we urge targeted action to facilitate safe production and transportation of medicines.

Our highest priority is to secure humanitarian corridors inside Ukraine for the safe passage of civilians and for the delivery of medicines to war-stricken cities. We deplore the military attacks on stocks of life-saving medicine and are deeply concerned about the lack of medicine for Ukrainians in the war-torn regions. We therefore plead with the EU to use all diplomatic channels with Russia to establish these vital corridors.

The EU had no choice but to apply extraordinarily strong sanctions against Russia to stop the war in Ukraine. We appreciate that medicines have been exempted for humanitarian reasons and we are working with our members to help them to comply with these important rules, notably the financial and the logistical limitations imposed by the international sanctions. There is, understandably, pressure to increase sanctions against Russia. We would therefore advise a closer dialogue between the relevant EU enforcement bodies and the medicines industry on finding the correct balance between the humanitarian need to supply medicines and the EU’s legitimate sanction policy to stop the war.

We encourage the EU Council to devote its full energy and authority to stop the war in Ukraine and to protect patients by securing access to medicines, while taking the necessary action to support our industry in achieving the same goal.

 

Medicines for Europe

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.

“Better patient access to medicines and restoring Europe’s (manufacturing) security of supply more critical than ever” says new President, as Elisabeth Stampa begins mandate

The Covid-19 pandemic has highlighted the critical link between patient access to medicine and a robust medicines manufacturing sector. As health systems begin to recover from the pandemic, a new crisis threatens stability and secure supply of medicines in Europe. This heightens the urgency to coordinate EU action on essential medicines and access to care, translating political statements into real policy reform.

 

Beginning her mandate as President of Medicines for Europe, Elisabeth Stampa (Medichem) outlined key policy priorities, requiring urgent EU action. These are:

  1. Facilitating sustainable API and medicines manufacturing in the EU to secure supplies for patients and healthcare systems in Europe.
  2. Ensuring competitiveness of the European off-patent API and medicines sector and a flexible and digital regulatory system that facilitates timely access for patients.
  3. Supporting the green transformation of API and medicines manufacturing.

 

Elisabeth’s Presidency marks the conclusion of the mandate of Rebecca Guntern (Sandoz), who has led the association ad interim over the past 6 months. Rebecca will continue her active engagement with Medicines for Europe in her role as association Vice President. She said: “It has been an honour to lead Medicines for Europe for this interim period. The off-patent industry continues to provide access to as many patients as possible, even under the most challenging circumstances. I wish Elisabeth all the best as she takes up the leadership challenge.”

 

Commenting on the launch of her mandate, Elisabeth said “seven out of every ten medicines dispensed in Europe are off-patent. Our industry has contributed significantly during the pandemic and now a major war begins on our borders. The contribution of the off-patent sector to the European healthcare system is key. Medicines for Europe’s interests are fully aligned with the EU’s pharmaceutical and industrial objectives. The time has come to translate objectives into reality. My priority as President will be to work with the EU to improve access to medicines and to restore the manufacturing competitiveness of Europe.

  1. This will include advocating for the elimination of short-sighted cost containment policies that aggravate the risk of medicines shortages and dependencies on other territories and ultimately harm patients.
  2. I want to ensure that the Intellectual Property system works as designed for the patient,facilitating access to the medicines they need.
  3. I want our association to embrace the digital and green transformation of healthcare, while continuing to provide high quality medicines to patients.

I count on our members, stakeholders and partners to respond to the challenges that lie ahead, ensuring we do everything in our power to build better access and health for every person in Europe.”

 

About Elisabeth Stampa, CEO, Medichem

With more than twenty years in the industry, Elisabeth is currently CEO of Medichem SA and serves on its Board. Since 2016, together with the Executive team, she has transformed the company from a pure API player into a vertically integrated B2B company. She has driven both innovation and sustainability initiatives within Medichem SA.

Prior to becoming CEO, Elisabeth was Executive Chair of the Corporate family business (Medichem SA and the former Combino Pharm SL), having started her career in Marketing at Laboratorios Esteve. She holds a BSc in Pharmacy (UB, Spain) and an MBA (ESADE Business School, Barcelona, Spain). She also serves on the Board of Trustees at the IQS in Barcelona.

Elisabeth has been an active member of international associations throughout her professional career and advocates for legislative changes that improve patient accessibility and strengthen the European industry at a global level. She represented EU API manufacturers on behalf of EFCG in the GDUFA II negotiations with FDA.

 

 

 

Medicines for Europe

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.