A new study “Value Added Medicines: Time to Adjust the HTA Decision Frameworks” was launched today in Brussels with the support of the Value Added Medicines Group, a sector group of Medicines for Europe. The study, conducted by Mondher Toumi, Professor of Public Health at Aix-Marseille University, highlights the need for adjustments in HTA decision frameworks to ensure that European patients can benefit from value added medicines. Professor Mondher Toumi emphasised that “value added medicines represent an opportunity for increasing the cost-effectiveness of treatments or services that may bring substantial value to individual patients and society. However, the current European HTA decision frameworks represent various challenges for the full value recognition of these products, which need to be addressed.”
According to the study, which counted on the important feedback of key HTA experts across Europe, value added medicines make a major contribution to patients’ quality of life, health outcomes or adherence, and address a number of medicine-related healthcare inefficiencies, improving healthcare provision and organisation while contributing to the sustainability of healthcare systems. The study underlines the importance of the eligibility of value added medicines for HTA, whenever requested, in order to demonstrate these relevant improvements. There is a need to adjust HTA decision frameworks to ensure that all benefits of value added medicines are appropriately captured and to ensure a patient-centric assessment. The manufacturers of value added medicines should also have the opportunity to get early HTA advice in order to better shape their clinical development plan. Professor Toumi commented that “taking into consideration the specific benefits of value added medicines will need efforts both on the research and policy fronts, but also the involvement of a broad range of stakeholders in the decision-making process”. Ten key recommendations are put forward in the report to ensure that value added medicines can be rightfully assessed by HTA decision frameworks in the future.
Umberto Comberiati, Chair of the Value Added Medicines Group ad interim, commented: ‘Research on known molecules is a valuable untapped opportunity for European patients and healthcare professionals alike. There is an urge to support research and adjust the HTA policy frameworks to encourage industry to invest in medicines with high potential value to patients and society and capitalise on healthcare professionals’ expertise. We are ready to work together with patients, healthcare professionals, policy makers and payers on how to ensure patients can benefit from value added medicines in Europe.”
Biosimilar medicines are transforming treatment by enabling better access to biological medicines in Europe and around the world, as stated today during the second day of the joint Medicines for Europe-IGBA conference in Lisbon. The IGBA (International Generic and Biosimilar Association) has commissioned new user-friendly material to acquaint and empower stakeholders with relevant information on the science and benefits of biosimilar medicines.
A new study on value added medicines highlights the necessary reforms in health technology assessment (HTA) decision frameworks in Europe to ensure market entrance of value added medicines to improve the treatment of chronic diseases in areas such as respiratory or mental health treatment. This innovative methodology will also enable new business models for value added antibiotics to address the growing threat of antimicrobial resistance.
Jacek Glinka, Medicines for Europe President commented: “Biosimilar and value added medicines can significantly improve healthcare for patients – if better access is pro-actively supported by all stakeholders. It took 25 years to create access for generic medicines, European patients cannot afford to wait that long for biosimilar medicines to come”.
Adrian van den Hoven, IGBA Chair highlighted that “The IGBA is committed to improving the information about the opportunities that biosimilar medicines can bring for patients around the world. We look forward to close cooperation with the WHO, governments and stakeholders to deliver better access to biological medicines”.
During the two-day conference, pharmaceutical industry leaders and key stakeholders from the generic, biosimilar and value added medicines sectors met in Lisbon to foster international partnership, cooperation and dialogue to address public health challenges for the future. Several key studies presented at the conference highlight the need for a major overhaul of medicines policies to stimulate more access to generic, biosimilar and value added medicines.
The International Generic and Biosimilar Medicines Association (IGBA) was founded as IGPA (International Generic Pharmaceutical Alliance) in March 1997 to strengthen cooperation between associations representing manufacturers of generic medicines. Its membership includes Medicines for Europe (Europe), the CGPA (Canada), the AAM (USA), the JAPM (Jordan), the Generic & Biosimilar Southern Africa (South Africa), the TGPA (Taiwan) and the JGA (Japan) while the associations from Australia (GBMA), Brazil (ProGenericos), Malaysia (MOPI) and Mexico (AMEGI) are Associate Members. The IGBA is at the forefront of stimulating competitiveness and innovation in the pharmaceutical sector by providing high quality pro-competitive medicines to millions of patients around the world. Through its constituent member associations, the IGBA maintains constant dialogue with government authorities (including the European Commission for Europe) as well as with international institutions such as WTO, WIPO and WHO. More information: www.igbamedicines.org
Over 100 participants explored different ways and opportunities to ensure universal access to healthcare, together with members of the European Parliament (MEPs) and healthcare stakeholders during the Universal Access to Health event that took place today in Brussels. At this year’s event, Medicines for Europe, the European Patients’ Forum (EPF), the European Public Health Alliance (EPHA) and the European Social Insurance Platform (ESIP) joined forces to explore ways to improve access to healthcare.
“This meeting offers a great opportunity to strengthen our work to date, through partnership with all relevant stakeholders supporting the current initiatives towards the achievement of the UN Sustainable Development Goal on Health, to ensure universal access and health coverage for all by 2030”. Nicola Bedlington, EPF Secretary General.
“The engagement of all stakeholders in pursuing the goal of universal access to healthcare is essential. Fundamental to this goal is the need to ensure the sustainability of healthcare systems and that of the social health insurances. In this respect, medical treatments must not only be available and affordable, they must also respect quality, efficacy and patient safety requirements”. Arnaud Emeriau, ESIP President.
“The access to medicines debate is a social justice issue in Europe today. We need a comprehensive dialogue on all issues with a balanced involvement of all stakeholders”. Yannis Natsis, EPHA Policy Coordinator for Universal Access & Affordable Medicines.
Speaking ahead of the event, Adrian van den Hoven, Medicines for Europe Director General, commented that “Medicines for Europe calls on the EU to stimulate competition in pharmaceutical markets post-patent where generic and biosimilar medicines have demonstrated their ability to massively increase access to medicines without raising the overall treatment costs, and where value added medicines can play a fundamental role to improve treatments and health outcomes”.
Medicines for Europe, EPF, ESIP and EPHA are looking forward to further progress and milestones promoting better access for better health and to meeting again in 2018 for the 5th Edition of Universal Access to Health.
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 employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation. 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.
Medicines for Europe Communications: Doris Casares doris@medicinesforeurope.com
/Andrea Bedorin abedorin@medicinesforeurope.com Phone: +32 (0)2 533 98 10
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EPF currently represents 74 members, which are national coalitions of patient’ organisations and disease-specific patient organisations working at European level. EPF reflects the voice of an estimated 150 million patients affected by various chronic diseases throughout Europe. EPF’s vision is that all patients with chronic and/or lifelong conditions in the EU have access to high quality, patient-centred equitable health and social care. The EPF strategic goals focus on areas such as health literacy, healthcare design and delivery, patient involvement, patient empowerment, sustainable patients’ organisations and non-discrimination. More information: www.eu-patient.eu
EPF Communications: Mr. Laurent Louette laurent.louette@eu-patient.eu Phone: +32 (0)2 280 23 35
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The European Social Insurance Platform (ESIP) represents over 40 national statutory social insurance organisations (covering approximately 240 million citizens) in 15 EU Member States and Switzerland, active in the field of health insurance, pensions, occupational disease and accident insurance, disability and rehabilitation, family benefits and unemployment insurance. The aims of ESIP and its members are to preserve high profile social security for Europe, to reinforce solidarity-based social insurance systems and to maintain European social protection quality. ESIP builds strategic alliances for developing common positions to influence the European debate and is a consultation forum for the European institutions and other multinational bodies active in the field of social security. For more information on our activities, go to www.esip.eu and follow us on Twitter @ESIP_EU
ESIP Communications: Christine Dawson chris.dawson@esip.eu Phone: +32 (0)2 282 05 62
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The European Public Health Alliance (EPHA) is a change agent advocating for better health. We are a dynamic member-led organisation, made up of public health NGOs, patient groups, health professionals, and disease groups working together to improve health and strengthen the voice of public health in Europe. EPHA is a member of, among others, the Social Platform, the Health and Environment Alliance (HEAL), and the Better Regulation Watchdog and SDG Watch Europe. http://www.epha.org
EPHA Communications: Giulia Vettore giulia@epha.org
The Value Added Medicines Group Participated for the First Time at the 22nd Congress of the European Association of Hospital Pharmacists Which Took Place 22-24 March in Cannes.
A special satellite symposium was organized on “Value added medicines – What value repurposed medicines might bring to hospital pharmacists”. Christoph Stoller, chair of the Value Added Medicines Group, chaired the session and opened with a short introduction to value added medicines. Professor Doctor Stephan Krähenbuhl, from the University Hospital of Basel, explained to the audience the importance of continuous innovation on existing molecules for the physician perspective. He presented several examples of repurposed medicines which benefited him in his work. Minodora Voiculescu, Medical Advisor at Fresenius Kabi, closed the presentations by focussing on the existing barriers for value added medicines in Europe and how hospital pharmacists can ensure their availability.
Key authorities, eminent lawyers and industry leaders discussed today in London the proposals put forward by the European Commission to stimulate jobs and growth in the pharmaceutical sector in Europe at the Medicines for Europe 13th Legal Affairs Conference. The high level participation at the event was crucial to advance discussions on key legal and IP topics impacting the generic, biosimilar and value added medicines industries.
This year’s conference addressed fundamental issues such as the consequences of the EU Health Council Conclusions of June 2016 calling for a review of pharmaceutical incentives, the impact of Brexit on the industry, antitrust developments, SPC case law, as well as interactive roundtables on the Unified Patent Court, orphan drugs, second medical use patents, clinical trial transparency, grace periods, the industry Code of Conduct, compulsory licenses, the Falsified Medicines Directive, EPO developments and data protection. The Commission proposal for an SPC manufacturing waiver for pharmaceutical production and R&D in Europe and to foster high-skill job creation and economic growth was discussed in depth.
“Today’s conference provides pathways to encourage competition, innovation and growth in the pharmaceutical sector. Patients, governments and healthcare systems rely on a strong generic, biosimilar and value added medicines industry to increase access to medicines and to create jobs for Europe”, commented Sergio Napolitano, Legal Affairs Director at Medicines for Europe, speaking ahead of the 13th Legal Affairs Conference, “an adapted legal environment that includes the SPC manufacturing waiver will boost investments in our sector and we stand ready to support job creation measures”.