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.
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.
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 |
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.
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.
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 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.
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:
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.
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.”
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 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.
Collaboration
Since the beginning of the war in Ukraine, Medicines for Europe immediately engaged with partners (Ukrainian Government and embassies, European Institutions, European Medicines Agency, civil protection agencies, national Strategic Reserve Agencies, World Health Organizaton and NGOs such as Médicins sans Frontières, Red Cross, International healthcare partners, Direct Relief, European Society for Paediatric Endocrinology, UAid Direct), to donate and supply medicines to Ukraine. We are also in contact with the crisis preparedness department of the Commission (HERA) to support with the supply of iodine and the European Civil Protection and Humanitarian Aid Operations (DG ECHO) to donate medicines to Ukraine. We have followed closely the requests of the Ukrainian Ministry of Health for essential medicines and circulated the regularly amongst our members who supply these medicines. These are essential medicines, mainly used in hospitals, in emergency care, required for surgeries, antibiotics, anti-inflammatory and analgesic medicines, as well as medicines used in cardiological, neurological, respiratory and infectious diseases and in the treatment of diabetes and cancer.
Financial and supplies donations
Our members have donated medicines, medical supplies, and financial donations directly to the defence effort in Ukraine. In Poland alone, our member Medicines for Poland has donated over one million packs of medicines worth approximately PLN 15 million. Our members have made cash donations to organisations providing assistance in the crisis situation and continue to do so as the situation continues.
Support for Ukrainian refugees
In border countries (Poland, Hungary, Slovakia), our members have allowed staff contribute during working hours to supporting and welcoming refugees coming from Ukraine. In the early days of the invasion, they supported the relocation of colleagues and their families from Ukraine to Poland/Slovakia/Hungary and guaranteeing the necessary support when they arrive. Inside their organisations, employees coordinate both collections of needed items and volunteering support. Our companies’ staff have organised volunteering initiatives in manufacturing sites to meet the increased demand for medicines during this time.
Support for employment opportunities
Our members have supported Ukrainian colleagues from the sector to find work in their country of relocation. Our members have medicines manufacturing sites and specialist functions in almost all EU countries, and integration of experts from Ukraine
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.
Political ambitions to strengthen EU supply chain resilience following the Covid crisis will not be successful unless economic and regulatory systemic reforms, such as on procurement, are put in place and provisions are made to access funds for the manufacturing of essential medicines.
Off patent medicines account for 70% of those dispensed in Europe for the most prominent diseases such as cancer, diabetes, cardiovascular care, infectious diseases, and others. Between 70-90% of Intensive Care Unit (ICU), and emergency medicines are off patent. Our sector currently has over 400 manufacturing sites in Europe.
The so-called Important Projects of Common European Interest (IPCEI) outline the political commitment to deliver on Europe’s vision for increased open strategic autonomy and build industrial capacity. However, major gaps exist in the current proposal. For the IPCEI to deliver for European industry and on access to medicines for patients, they must:
• Encourage access to manufacturing incentives such as funds to support investments in new technology and innovation by including the API and off-patent industry in the health IPCEI project
• Make EU funds and recovery funds available to support green and digital production and technology transformation to reinforce our strong European manufacturing footprint vs. competing geographies
In parallel, the State Aid Framework should enable the generic medicines and API industry to participate in national recovery and resilience plans for green and digital technology investments and to enhance medicines production.
Commenting ahead of an event organised by the French Presidency of the EU, Medicines for Europe Director General Adrian van den Hoven said “We learned a lot of lessons about the vulnerability of medicines supply the hard way during the pandemic. It is right and should be commended that we reflect on improving our medicines manufacturing footprint in Europe. But to develop IPCEIs that do not provide for the API or off-patent sector would be a mistake. These are essential medicines that millions of people rely on daily and are first line in an emergency. As war breaks out on our eastern border, there is still time to make the IPCEI framework right. We call for the IPCEI on health to include manufacturing of essential, life-saving off patent medicines and related APIs.”
Resource hub
The French Presidency is hosting a conference to discuss recommendations for an industrial policy for healthcare and the details of the IPCEI on health on 03 March 2022.The proposal currently does not provide scope for manufacturing of active pharmaceutical ingredients (API) or off patent medicines. More details on the conference can be found here https://presidence-francaise.consilium.europa.eu/en/news/towards-an-independent-competitive-and-innovative-european-healthcare-sector/
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.