Medicines have a unique value to public health and society at large. They are vital for our wellbeing, either to manage serious conditions such as cancer, diabetes, bacterial infections, cardiovascular diseases, auto-immune conditions, or to prevent illness and manage symptoms that allow everyone to carry on with their lives.
Inflation across Europe has risen beyond 10%. This increases the manufacturing costs of essential, off patent medicines, which account for 70% of those dispensed in Europe. These medicines treat serious, debilitating conditions such as cancer, diabetes, cardiovascular diseases, and auto-immune conditions.
The EU plans to update its 20-year-old pharmaceutical legislation early next year to improve access to medicines and to make innovation more affordable. The introduction of biosimilar medicines was one of the pioneering and most successful reforms of the previous legislation in 2004. Now we need to update the legislation to make it fit for the future. Open
Nurses in all health domains and specialities play a crucial role in the management of patients with serious noncommunicable diseases such as cancer, auto-immune conditions, and diabetes. The incidence of these diseases is increasing, and more patients require biological therapies to manage their condition.
Learn more in the ESNO guide Switch Management between Similar Biological Medicines
Listen to the third episode our Podcast: The Nurses’ voice on Biosimilar Medicines. An opportunity for Integrated Care
For the last decade, off-patent medicines, which represent the 70% of dispensed medicines in the European Union, have been subject to strict price regulation, budget austerity measures, and lowest-price tender rules, causing substantial price erosion and an unsustainable situation for manufacturers. This has been exacerbated by the Covid-19 crisis and the war in Ukraine, which has dramatically increased general inflation (now over 9%), raw material costs (risen by between 50-160%), transportation costs (up to 500%) and energy prices.
Read the full Open Letter to EU energy Ministers
The Biosimilar medicines group, a Medicines for Europe sector group, is pleased to note the EMA/HMA jointly closing the discussion on biosimilar medicines interchangeability.
The statement reflects a harmonised view on today’s common clinical practice in many European Member States whereby prescribers and their patients can safely choose from all available authorised options of a given medicine and ‘without a patient experiencing any changes in the clinical effect’.
REMEDi4ALL launched yesterday with the aim of making a major leap forward in drug repurposing. This promising approach to drug development consisting in the identification, testing, and validation of new therapeutic indications for existing medications, is a developing field but faces numerous barriers and systemic inefficiencies. Still, its potential to significantly bring down times and costs of drug development -it focuses on already approved, discontinued, shelved or investigational therapeutics- makes this novel strategy attractive for rare and neglected conditions, cancer, emerging public health threats such as COVID-19 or new drug combinations. It also translates into more sustainable health systems.
The REMEDI4ALL initiative will:
EATRIS, the European infrastructure for translational medicine, will lead this multidisciplinary consortium involving 24 European organisations with the common goal of making cost-effective repurposed medicines more widely available.
To advance knowledge in the field of medicine repurposing and address substantial obstacles -fragmented and siloed research; non-standardised datasets; heterogenous quality of computational tools; poor patient engagement or lack of incentives and policies to support and enhance drug repurposing- the European Union (EU) through the Horizon Europe (HE) programme will invest 23 million euros in REMEDi4ALL over the next 5 years. It is expected that, due to REMEDi4ALL, more (and better) repurposed therapeutics will be widely available thanks to more agile, cutting-edge development processes, ultimately contributing to increased sustainability of health systems.
A favourable eco-system for drug repurposing
The project kicks off with the ambition of establishing a European research and innovation eco-system that facilitates fast and cost-effective patient-centric development and access to repurposed medicines. To this end, REMEDi4ALL will:
REMEDi4ALL has selected four medicine repurposing projects in different stages of development to demonstrate the viability of the newly created platform. Each project covers a different therapeutic area with high unmet medical needs– pancreatic cancer, COVID-19, rare diseases and ultra-rare diseases. These projects will first be onboarded to ensure a patient-centric approach before testing all elements of the platform to optimise its tools and services.
A multidisciplinary effort to cover every aspect of drug repurposing
The REMEDi4ALL consortium brings together a unique combination of expertise to address the complexities of drug repurposing. Under the leadership of EATRIS, the European infrastructure for translational medicine, 24 organisations in the fields of clinical and translational research, clinical operations, patient engagement and education, regulatory framework, funding, governance, Health Technology Assessment (HTA) or pricing and reimbursement will closely collaborate to make drug repurposing mainstream.
“It’s an enormous privilege to work with this team of leading international experts, institutions and patient representatives in such an important and high potential area for European health. REMEDI4ALL will truly transform drug repurposing by making the process more transparent, efficient and – most importantly – completely patient-centred” expressed Anton Ussi, CEO at EATRIS ERIC.
The 24 partners participants include:
Links:
The Value Added Medicines Group, a sector group of Medicines for Europe, joins the initiative as a member of the REMEDI4ALL consortium. Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its member companies play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create Value Added Medicines, including repurposed medicines, by tackling patients’ needs that remain unmet to this day and delivering additional improvements to the healthcare community as a whole.
Contact & interviews:
EATRIS
Jake Fairnie
Teamit Research
Gisela Pairó
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.
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.
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.