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.
Reports of supply shortages of breast cancer medicine (Tamoxifen) in Germany raise legitimate concerns for patients and highlight the difficulties faced by off-patent medicines manufacturers operating in markets driven by cost-containment policies. For the generics industry, the priority is to avoid bottlenecks in supply as far as possible and make sure patients can continue to access the medicines they need. We must then urgently address the universally strict cost-containment measures, which force generic medicines prices into a dangerous downwards spiral, often below the cost of goods, which are currently rising driven by steep levels of inflation.
When cases of limited supply of essential, off-patent medicines occur, the root of the issue can usually be identified by asking three key questions:
This is indicative of a growing trend, also highlighted by the Technopolis Study on Medicine Shortages, of generic market policy failures caused by disproportionate and short-sighted cost-containment measures combined with rapid increases in inflation.
We call on the EU and national authorities to put patients first and to start correcting the functioning of unsustainable procurement and tendering policies in the EU. This means to:
The priority of Medicines for Europe members is to stabilise patient access to essential medicines. We must be met with realistic proposals and policies from our partners to address this continued situation and find real solutions for essential medicines and the patients who rely on them.
Resource hub
For more information on the situation in Germany, see https://www.progenerika.de/presse/tamoxifen/ and Q&A on https://www.progenerika.de/updates/lieferengpaesse-beim-brustkrebs-wirkstoff-tamoxifen/
Medicines for Europe position on medicines shortages https://www.medicinesforeurope.com/docs/20170927_Positionpaper_medicines%20shortages.pdf
Over 15 years ago, the world’s first biosimilar was launched. This was very much a European success story, with the European Medicines Agency leading the way to bringing more affordable biologics to patients. Biosimilars have had a tremendous impact on:
However, more needs to be done to achieve equitable access to biologics in Europe.
As stressed in the IQVIA 2021 Impact of Biosimilar Competition report: “Not all European countries have been either willing or able to increase access to biological medicines in the available therapy classes2”. There remains a lot that countries across Europe can do to increase the use of biosimilars and close access gaps, for the full benefits of patients. The Pharmaceutical Strategy for Europe must help unlock the full potential of biosimilar medicines. These calls have been echoed by the European Parliament in the report on the EU pharmaceutical strategy3 and EU beating cancer plan4.
Isabell Remus, Chair of the Biosimilar Medicines Sector group of Medicines for Europe, said: “The access gaps will not close by themselves, this requires conscious policy-making that puts biosimilar medicines – and patients — at the centre. This can only happen with strong political leadership to drive the right mix of policies. The European Commission has been a strong ally in the past 15 years and we very much count on its leadership to keep shaping the right environment for biosimilars over the next 15 years.”
Note
The policy framework for biosimilar medicines will be discussed at a stakeholder focused webinar, entitled “15 Years of Biosimilars: Improving Equitable Access to Essential and Affordable Biological Medicines in Europe”. The webinar will take place at 11.30-13.00 CET on Tuesday 25th January. For more, see here.
THE BIOSIMILAR MEDICINES GROUP
The Biosimilar Medicines Group is a sector group of Medicines for Europe representing the leading companies developing, manufacturing and/or marketing biosimilar medicines across Europe. With more than 15 years of positive patient treatment experience, biosimilar medicines provide today a huge opportunity to deliver significantly improved access to modern therapies for millions of European patients in both chronic and acute care. Our members bring competition to the biological medicines market, thereby increasing access to highly innovative treatments to patients, in Europe and around the world, and supporting the sustainability of the European healthcare systems.
The ongoing review of the EU pharmaceutical legislation framework is a major opportunity to update the EU regulatory system. Future reforms should focus on a system that delivers meaningful benefits to patients, particularly timely access to medicines supported by efficient regulatory processes, readily accessible information on medicines and better systems to manage medicines shortages.
The off-patent medicines sector accounts for almost 70% of medicines dispensed in Europe, helping to manage the most prevalent chronic diseases including cancer, auto-immune conditions, cardiac disease and diabetes. The regulatory framework must be tailored so that these medicines can readily get to the patients and healthcare professionals who need them.
The upcoming review of the EU pharma legislation should prioritise the following regulatory initiatives:
Speaking at the Medicines for Europe regulatory affairs conference, ad interim President Rebecca Guntern said: “It’s almost impossible to exaggerate the extent to which access to affordable off-patent medicines depends on a fit-for-purpose and fully-digitalised regulatory framework. The proper functioning of this system is absolutely critical, both to get the right medicine to the right patient at the right time today and to ensure the sustainable development of the industry to meet the patient needs of tomorrow.”
The series of regulatory affairs webinars will take place between January 24th and 09th February. For more details, and to register, please visit https://www.medicinesforeurope.com/events/racphv2022/
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.