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.