Dr Patricia Vella Bonanno CPSU 7 th Annual

Dr. Patricia Vella Bonanno CPSU 7 th Annual Suppliers Conference 29 th November 2019

Ministers for Health: - conscious of the importance of guaranteeing patients’ access to new and innovative medicines and therapies while ensuring the sustainability of their health systems - agreed to cooperate in full trust, loyalty, solidarity and transparency for better access to medicines

Signed in Malta on 8 th May 2017 during Malta’s Presidency of the European Council by Cyprus, Greece, Italy, Malta, Portugal, Spain • Ireland Romania joined on 9 th May 2018 • Slovenia on 30 th January 2018 • Croatia on 4 th May 2018 over 160 million citizens 31, 5% of EU population

Valletta Declaration • Ministerial Committee • Ministers of the signatory countries • Give direction and set the agenda • Ministerial commitment and support • Valletta Technical Committee • Voluntary cooperation • Activities include sharing of information, identifying best practices, horizon scanning and price negotiation • Currently Chaired by Italy, Portugal Vice-Chair, Malta Secretariat

Meetings of the VTC Meeting no. Host country Date 1 Cyprus 29 -06 -2017 2 Italy 03 -10 -2017 3 Spain 30 -01 -2018 4 Portugal 04 -05 -2018 5 Greece 11 -07 -2018 6 Romania 7 Croatia 28 -02 / 01 -03 - 2019 8 Malta 11 / 12 -07 - 2019 26/27 – 11 - 2018

Exchange of information on medicinal products, on policies for the use of medicines and good practices • • policies for the use of biosimilars access and financing of CAR-T cell therapies reference pricing shortages of medicines reimbursement of products by different countries sharing of effectiveness assessments of medicines models for combatting anti-microbial resistance

Exchange of information on prices of medicines • Sharing of information on prices of medicines and on conditions /criteriafor negotiation - issue of lack of transparency • WHO Resolution “Improving the transparency of markets for drugs, vaccines and other health-related technologies” adopted during the 72 nd session of the World Health Assembly in May 2019 - proposed by IT, co-sponsored by other countries including a number of countries signatory to the Valletta Declaration - implementation of the recommendations

WHO Resolution “Improving the transparency of markets for drugs, vaccines and other health-related technologies” Urges MS in accordance with their national and regional information to: - Take appropriate measures to publicly share information on the net prices of health products - Take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and if already publicly available or voluntarily-provided, costs from human subjects clinical trials - Work collaboratively to improve the reporting of information by suppliers on registered health products - Facilitate improved public reporting of patent status information and marketing approval status of health products - Improve national capacities, including through international cooperation, open and collaborative research for development and production of health products

Joint assessment and negotiation for candidate products • • • Identification of candidate products based on criteria Nomination of two rapporteur countries for each product To date none of the companies approached for the process accepted Concerns included: - what price is to be set (maximum price or fixed price), - negative joint outcomes, - transparency of the process If a company submits application in one of the Member countries, the process cannot continue

Thank you