Strengthening Member State collaboration on improving access to medicines in the WHO European Region
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Dr. Hans Kluge, Director, Division of Health Systems and Public Health and Hanne Bak Pedersen, Programme Manager, Health Technologies and Pharmaceuticals, WHO Regional Office for Europe (67th session of the WHO Regional Committee for Europe)
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Strengthening Member State collaboration on improving access to medicines in the WHO European Region
- 1. (1) Strengthening Member State collaboration on improving access to medicines in the WHO European Region Dr. Hans Kluge Director, Division of Health Systems and Public Health Hanne Bak Pedersen Programme Manager, Health Technologies and Pharmaceuticals
- 2. (2) Access to medicines and technologies Globalcommitments WHA 28.66 Ljubljana Charter Set of principles for reforming health systems in Europe WHA60.16 Tallinn Charter Commitment to health systems strengthening Health 2020 Commitment to people- centred health systems WHA 69.25 EUR/RC65/R5 Sustainable Development Goals 1975 1977 1988 2013 2014 First model list of essential drugs Alma-Ata Declaration WHA 41.16 WHA47.13 WHA 67.20, 67.21, 67.22WHA61.21 EB132.R4 WHA 67.25, 68.7 1975 1977 1978 1988 1994 1996 2007 2008 2012 2013 2014 2015 2016
- 3. (3) Working towards country cooperation to improve access to medicines in Europe 2014 2015 2016 2017 2018+ Prospective country collaboration on technical capacity for strategic procurement
- 4. (4) The process: timeline and milestones towards the 67th session of the Regional Committee (RC67) RC66 Technical briefing on access to high price medicines First summer school on pharmaceutical pricing and reimbursement policies Initial draft of the Standing Committee document on Strengthening Member State collaboration on improving access to medicines in the WHO European Region Consultation at Standing Committee Quality & regulation training workshop Online consultation with Member States Meeting on strategic procurement of medicines Meeting on strategic procurement & horizon scanning collaboration RC67 Strengthening Member State collaboration on improving access to medicines in the WHO European Region Consultation at Standing Committee Pharmaceutical Pricing and Reimbursement Information network meeting for Commonwealth of Independent States Aug. 2016Aug. 2016 Sep. 2016 Jan. 2017 Feb. 2017 March.2017 May 2017 June 2017 Sep. 2017 Second summer school on pharmaceutical pricing and reimbursement policies Dec. 2016 Consultation at Standing Committee The first WHO report on antimicrobial medicines consumption
- 5. (5) RC67 Decision – Strengthening Member State collaboration on improving access to medicines in the WHO European Region The Regional Committee: • WELCOMES the report on strengthening Member State collaboration on improving access to medicines in the WHO European Region • SUPPORTS the WHO Regional Office for Europe’s focus on pricing and reimbursement, strategic procurement, and information-sharing and mutual learning as three key areas for action, and requests the Regional Office to support the efforts of Member States and to facilitate collaboration to advance the access to medicines agenda in the European Region • SUPPORTS the proposed WHO actions elaborated in the report depending on available resources • CALLS FOR the Regional Office to take stock of Member State interest and commitment in these areas over the course of this biennium, while ensuring synergy and continuity with global processes and directions.
Editor's Notes
- Dear Ladies and Gentlemen, it is a pleasure for me to address you today on the topic of access to medicines as part of the work we are undertaking moving towards universal health coverage. In the European region’s 53 countries, there are different stages of health systems development and reforms to achieve universal health coverage. Access to essential medicines has not been adequately addressed in many countries and there is in some countries a substantial out-of –pocket payment for medicines. Where there is a high-out of pocket payments for medicines this is causing substantial financial burden to individuals and families. The introduction of new high-priced medicines in Europe is challenging for most countries and for some these medicines remains un-affordable. World Health Assembly Resolution (WHA67.22, 2014) called on to Members states "to promote collaboration and strengthen the exchange of information on best practices in the development, implementation and evaluation of medicine policies and strategies that enhance access to affordable, safe, effective and quality-assured essential medicines". This session covers work undertaken and foreseen by the Regional Office to support countries in advancing access to medicines through cross-country collaboration in the Region.
- As you can see, Access to Medicines and Technologies has long been an important topic on the global health agenda. In recent years, things have accelerated, as illustrated by the number of resolutions on this topic that have been adopted by the World Health Assembly. These include for instance: Resolution A61.21 (2008) on the Global strategy and plan of action on public health, innovation and intellectual property Resolution A67.20 (2014) on Regulatory System Strengthening for Medical Products Resolution A68.7 (2015) on the Global Action Plan on antimicrobial resistance Resolution A69.25 (2016) on Shortages of medicines & vaccines
- From these challenges, opportunities of collaboration rose. As this slide shows, there is considerable appetite for structured country collaboration to improve access to medicines in the European Region. With Member State-driven initiatives above the date line, and WHO actions below, you can see that things are developing very much in tandem. Highlights at country level include: CLICK An initial report by Bo Könberg under the Nordic Collaboration calling for increased cooperation between countries in health; In 2012, Estonia, Latvia and Lithuania (The Baltic countries) signed a partnership agreement to conduct joint procurement of medicinal products and lending of medicinal products. The first joint tender for BCG vaccines was conducted in 2015, followed by a joint tender for rotavirus in 2016 and for pneumococcal conjugated vaccine in 2017. In November 2016, the Health Ministers of Bulgaria and Romania have signed a bi-lateral agreement to initiate joint negotiations on expensive medicines. CLICK Also in November 2016, health ministers from Eastern Europe and Central Asia gathered in Minsk, Belarus, adopted a Consensus Statement on "HIV and TB treatment for all”. The countries committed to strengthen regional cooperation in order to advance access to affordable and quality medicines and deliver more cost-effective, equitable and sustainable solutions for common challenges by intensifying efforts through regional solidarity, shared responsibility and political leadership. CLICK The BeNeLuxA initiative, initially between Belgium, Luxembourg and the Netherlands now also include Austria. Further extension of country collaboration has been envisaged - recently on 27th June 2017 - a joint horizon scanning project was launched inviting other EU member states to join them. CLICK The Dutch and Maltese EU Presidency agendas which included access to medicines as a key item and CLICK the Estonian EU Precedency which focus of efficiency in regulation of medical products ( conference 8-9 Nov 2017, “Safer Europe without falsified medicines”) In addition, the Austrian Presidency in 2018 is also going to include medicines as an important area of focus. Finally, in May 2017, nine European countries (Cyprus, Greece, Italy, Ireland, Malta, Portugal, Romania, Slovakia and Spain) signed an agreement to engage in collaboration on joint price negotiation for medicines. First meeting was held end of June 2017 in Cyprus. From WHO and the Regional Office’s side, a lot of activities have been conducted in recent years: CLICK A wide-ranging technical report on policies and priorities in introducing new high-price medicines was published in 2015; CLICK A technical briefing on high-price medicines took place at the last Regional Committee; CLICK A report and technical expert meetings on options around strategic procurement and horizon-scanning took place in September 2016 feeding into the proposed document for consideration at the 67th sitting of the Regional Committee in September this year. The Regional Office also conveyed a meeting in February 2017 to discuss opportunities for collaboration in the area of horizon scanning in Europe. There is a huge interest among countries to exchange on how to best coordinate in this activity in order to improve systems and avoid duplications. CLICK Finally, the Fair Pricing Forum held in Amsterdam in May 2017 gathered more than 200 stakeholders and competent authorities on medicines pricing policies from across the globe. The forum discussed options for a fairer pricing system – one that is sustainable for both health systems and innovation. The topic of one of the break-out sessions was on voluntary collaboration among countries.
- The Regional Office for Europe seeks to provide support to Member States in the areas where they face challenges. In the recent year a number of important activities have been undertaken as illustrated in this slide: Pricing and reimbursement The PPRI network initially started with the financial support of EU commission is still a very useful cross country forum for collaboration. Two summer schools have been held and as only few CIS countries are members of PPRI and as pricing and reimbursement policies are under development in most of these countries a pricing and reimbursement meeting for of the Commonwealth of Independent States was held 13–14 June 2017 in Chisinau (Moldova) organized by WHO Euro and WHO CC for Pharmaceutical Pricing and Reimbursement Policies. It discussed the creation of a network of competent authorities in the field of pricing and reimbursement of medicines in the CIS countries. Participants from Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan attended the meeting. Quality& regulation - Two training workshop on medicines regulation were held this year – one fussing on assessment of quality of medicines – and another on the implementation of the WHO guidelines of Biotherapeutics including biosimilars in Russian speaking countries. There is a critical need in creating understanding and trust in the biosimilar area, in order to promote access to these products as well as to ensure their quality, safety and efficacy. The role of WHO is to support national regulatory authorities to develop national regulatory frameworks to meet current/ international regulatory expectations Support has also been provided to the revision of the law on medicines ( Kyrgyzstan, 2017), development of the pharmaceutical national policy (Ukraine, 2016-2017), support in finalizing the draft legislation related to HTA (Greece, 2017). Strategic procurement -A knowledge sharing network on strategic procurement in collaboration with UNICEF has been evolving over the past years. WHO Regional office for Europe is also developing with LSE Health a 3 day workshop ( end of September 2017 , Copenhagen, Denmark) for countries in the region to share best practices on strategic procurement of high-priced medicines. The objective of the workshop is to build practical skills in preparing and conducting negotiations with a refresher on negotiation concepts. Drug utilization & Prescription The first WHO report on antimicrobial medicines consumption (AMC) was published by our office in April and this report sets out and analyses data on antimicrobial medicines consumption collected from non-European Union countries in the WHO European Region and Kosovo (in accordance with Security Council resolution 1244 (1999)). Its aims are to support countries that are building or strengthening their national surveillance systems on AMC and to stimulate the sharing of data both within and between countries. The WHO Regional Office for Europe and its partners remain committed to supporting countries in these endeavours through the activities of the WHO AMC Network. The 2017 AMC network meeting took place 3-4th July 2017, Copenhagen , Denmark. Participants from 17 non-EU countries joined to discuss on reporting and monitoring data for antimicrobial resistance and of consumption of antimicrobials. There was a particular focus on sharing the changes to Antibacterials in the 2017 EML and EMLc so as to explain the principles to prioritize the selection of Antibiotics and work towards improving stewardships in the use of Antibiotics. As also can be seen from this slide there has been consultation with MS and SCRC on the document in question and we thank you for your important input in this regard.
- The Regional Office for Europe seeks to provide support to Member States in these areas in an effective, integrated and evidence-informed manner, and to promote debate and discussion on important topics with regard to access to medicines and the wider pharmaceutical sector. Political will and mutual trust among Member States are, however, essential for the success of future collaboration. Sharing best practices will be our road map for action but more specific topics such regulation, pricing and reimbursement and strategic procurement will be of particular attention. This DECISION asks for your approval on the following three areas for action: Pricing and reimbursement - An extension of the PPRI network of competent authorities in the field of pricing and reimbursement of medicines to better cover challenges faced in the CIS countries. This will include participants from Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan Strategic procurement -A knowledge sharing network on strategic procurement to build practical skills in preparing and conducting efficient procurement of medicines Information sharing and mutual learning - Here our focus remains on efficient regulation of medicines along with responsible use of medicines – including antibiotics
- The access to medicines agenda has also been given additional impetus through the 2030 agenda, which offers a fantastic opportunity for a sustained global and regional effort to ensure that everyone has access to the affordable, quality medical products they need to be healthy and productive over the life-course. It represents a shift of focus from specific diseases and population targets to a more comprehensive approach to health. SDG target 3.8 which focuses on the pursuit of universal health coverage (UHC) in all countries stresses “access to safe, effective, quality, and affordable essential medicines and vaccines for all”. This new agenda provides a clear case to scale up work on strengthening pharmaceutical systems as part of health systems strengthening, taking into account the growing need for a wider range of health technologies. The SDG agenda also feeds WHO EURO framework of priorities for health systems strengthening strategy for the period 2015-2020, which also identifies innovation and access around medicines and health technology as one of the three pillars of health systems strengthening.