Pharmaceutical industry leaders and key stakeholders from the generic, biosimilar and value added medicines sectors are meeting in Lisbon, Portugal 14-16 June to foster international partnership, cooperation and dialogue to address public health challenges for the future during the joint 23rd Medicines for Europe and 20th IGBA Annual Conference. In addition to international regulatory cooperation, several key studies were presented at the conference that highlight the need for a major overhaul of medicines policies to stimulate more access to generic, biosimilar and value added medicines.
Generic medicines now account for the lion’s share (62%) of Europe’s medicines according to the latest data from Quintiles IMS. As the primary industry responsible for providing medicines to patients, we take our public health responsibilities seriously. To sustain this access, it is essential that unsustainable medicine pricing policies are reformed, as they are massively increasing the risk of serious medicines shortages – as outlined in a report by the Economist Intelligence Unit.
Jacek Glinka, Medicines for Europe President commented: “With Generic medicines accounting for 62% of all medicines dispensed in the EU, we call on EU payers to refrain from imposing unsustainable pricing policies that lead to medicines shortages and EU regulators to increase regulatory cooperation to reduce administrative redundancies”.
“We need to implement the recommendations of the WHO Fair Pricing Forum: dialogue between regulators, payers and industry should tackle unsustainable procurement policies”, added Adrian van den Hoven, Chair of the IGBA.
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
The European Semester Country Specific Recommendations show that healthcare systems need to improve in terms of efficiency. The EU commitment to ensuring equity of access to healthcare is challenged by the limited financial capacity of governments to cover growing demand for healthcare services. Generic and biosimilar medicines provide the greatest opportunity to improve access to safe and effective medicines through efficient medicines policies.
Governments should adopt medicines policies that support the use of generic and biosimilar medicines to generate the sustained benefits of competition over the long-term. Short-sighted and radical cost-containment measures (such as External Reference Pricing (ERP), single winner tendering, payback/clawback policies and mandated price cuts), endanger medicines supply reliability and ultimately patient health, as is underlined in the Commission’s assessment of the situation in Romania.
Adrian van den Hoven, Director General at Medicines for Europe commented that “The OECD[1], the European Commission[2],[3] and the European Council[4] have highlighted the importance of the timely availability of generic and biosimilar medicines for healthcare systems. In this light, Medicines for Europe has developed a set of Country Recommendations for France, Italy, The Netherlands, Spain, Portugal, Bulgaria and Ireland to help the EU and member states develop effective policies that support access to medicines for patients”.
To fully realise the potential of generic and biosimilar medicines, European governments should encourage competition from generic and biosimilar medicines based on four overarching recommendations as well as specific measures for each country:
More details on the Medicines for Europe recommendations can be found here.
[1] OECD, Fiscal Sustainability of Health Systems: Bridging Health and Finance Perspectives, 2015
[2] Investing in Health, 2013, DG SANCO, European Commission, http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf
[3] DG ECFIN and Economic Policy Committee (Ageing Working Group), Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability, 2016, http://ec.europa.eu/economy_finance/publications/eeip/ip037_en.htm
[4] Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States – http://www.consilium.europa.eu/en/press/press-releases/2016/06/17-epsco-conclusions-balance-pharmaceutical-system/
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
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”.