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.
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.