Regulamento sobre Avaliação das Tecnologias de Saúde e Grupo La Valetta Heitor Costa, Director Executivo da APIFARMA 1 Cross-Country collaborations • Historical ties (except Valetta) ⚑ Iceland BeneluxA • Countries move… Finland Valetta Declaration ⚑ IE and LT belong to 2 CCC’s Norway ▼ Iberia partnership Sweden Estonia Visegrad+ • Not part of any CCC: Latvia Denmark⚑ FR, UK, DE and… BU, CH Baltic Partnership Lithuania Ireland Poland Nordic Council Netherlands • North vs South/East Nordic Tendering pilot ⚑ Belgium Czech led by AMGROS Luxembourg Republic Slovakia FINOSE Austria Hungary Slovenia Romania Italy Croatia ▼ ▼ Portugal Spain Greece Cyprus Malta 2 Cross-Country collaborations Nordic collaborations ⚑ Nordic tendering pilot (Denmark, Norway, Iceland) led by AMGROS ⚑ • September 2018: call for 2 off-patent Iceland products BeneluxA • Innovative medicines as a second iteration Finland not excluded Valetta Declaration ⚑ Norway • Combination of strong political will and ▼ Iberia partnership Sweden expertise Estonia Visegrad+ • Industry has been very active already Latvia locally (engagement, legal analysis…) Denmark⚑ Baltic Partnership Lithuania Ireland Poland Nordic Council Netherlands Nordic Tendering pilot ⚑ Belgium Czech ● FINOSE (Finland, Norway, Sweden) led by AMGROS Luxembourg Republic Slovakia FINOSE • Collaboration on HTA/REA Austria Hungary Slovenia Romania • High-level meeting on 27 March 2018 Italy Croatia • Evaluation of the initiative planned late 2020 ▼ ▼ • Actively reaching out to companies Portugal Spain Greece Cyprus Malta 4 Cross-Country collaborations ⚑ Iceland BeneluxA Finland Visegrad (V4+) Valetta Declaration ⚑ Norway • 2 March 2018 Bratislava meeting ▼ Iberia partnership Sweden • 2 competing companies invited, Estonia Visegrad+ originally to negotiate prices of their Latvia products Denmark⚑ Baltic Partnership Lithuania • Hungarian cabinet still committed; no Ireland Poland high-level political impetus yet since last Nordic Council Netherlands political reshuffle in April 2018 Nordic Tendering pilot • Legal framework reportedly competed ⚑ Belgium Czech led by AMGROS Luxembourg Republic Slovakia (June 2018) FINOSE nd Austria Hungary • Next round of discussion 2 half of Slovenia Romania September Italy Croatia ▼ ▼ Portugal Spain Greece Cyprus Malta 5 Cross-Country collaborations BeneluxA-I ⚑ • Ireland joined (22 June 2018) Iceland BeneluxA • Horizon Scanning • Call for tender announced (Sept. Finland Valetta Declaration ⚑ 2018) Norway • EFPIA-Pharma.be outreach (July ▼ Iberia partnership Sweden Estonia 2018) Visegrad+ • First positive reimbursement decision Latvia Denmark⚑ following joint price negotiation with Baltic Partnership Lithuania Ireland Belgium and Netherlands (11 July 2018) Poland • Other pilot joint-negotiations on-going Nordic Council Netherlands (expensive medicines) Nordic Tendering pilot ⚑ Belgium Czech • Reaching out to companies for joint led by AMGROS Luxembourg Republic Slovakia assessment FINOSE Austria Hungary Slovenia Romania Italy Croatia • www.beneluxa.org updated ▼ ▼ Portugal Spain Greece Cyprus Malta 6 Beneluxa-I First pricing & reimbursement negotiation concluded Common reimbursement conditions in Netherlands and Belgium announced on 12 July 2018 Joint HTA assessment Joint pricing negotiation Agreement concluded until end-2020 Manufacturer to collect Real World Evidence and carry out further research Question for other BeneluxA-I members, where the product is NOT reimbursed? 7 Cross-Country collaborations European Snapshot Nordic Tendering (Led by AMGROS) ⚑ • Pilot for joint tendering (Denmark, Norway, Iceland) to materialise in September 2018 – off-patent products • Innovative medicines as a second iteration not excluded ⚑ Baltic Partnership Iceland • Currently limited to joint tendering of vaccines BeneluxA Finland Valetta Declaration ⚑ V4+ Norway • No known development since 2 March 2018 Bratislava ▼ Iberia partnership Sweden meeting Estonia • Hungarian cabinet still committed; no high-level political Visegrad+ impetus yet since last political reshuffle in April 2018 Latvia Denmark⚑ Baltic Partnership Lithuania Valetta Declaration Ireland • 3-4 May 2018 meeting in Lisbon – Croatia now a Poland member Nordic Council Netherlands • 11 July 2018 meeting in Athens (November meeting in Nordic Tendering pilot Bucharest) ⚑ Belgium Czech led by AMGROS Luxembourg Republic • 2 products reportedly under consideration Slovakia • Methodological issues under resolution FINOSE Austria Hungary Slovenia Romania BeneluxA Italy Croatia • Ireland joined - 22 June 2018 • Horizon Scanning: Call for tender announced Sept. 2018 ▼ ▼ • Reaching out to companies for joint assessment Portugal Spain Greece • First successful joint pricing negotiations BE-NL July 2018 Cyprus • www.beneluxa.org updated Malta 8 Cross-Country collaborations ⚑ Iceland BeneluxA Valetta Declaration • 3-4 May 2018 meeting in Lisbon Finland Valetta Declaration ⚑ • Croatia now a member Norway ▼ Iberia partnership Sweden • 11 July 2018 meeting in Athens Estonia • November meeting in Bucharest Visegrad+ • 2 products reportedly under consideration ⚑ Latvia Denmark • Methodological issues under resolution – Baltic Partnership Lithuania Ireland (legal framework) Poland Nordic Council Netherlands • Internal divergences among membership Nordic Tendering pilot ⚑ Belgium Czech led by AMGROS Luxembourg Republic Slovakia FINOSE Austria Hungary Slovenia Romania Italy Croatia ▼ ▼ Portugal Spain Greece Cyprus Malta 9 Valetta Declaration 5th Meeting 10-11 July 2018, Athens ✱ Attendance • Ministers from Portugal, Romania, Greece, Cyprus, Malta + a secretary of state from Italy • Valetta Technical Committee met in parallel ✱ MoH Xanthos reportedly made a proposal intending to address most gaps • International Convention • Roadmap ✱ Bilateral cooperation between Cyprus and Greece considered (pricing) ✱ Non-alignment between members reported informally following the meeting ✱ Next meeting in Bucharest, Romania (November 2018) 10 Valetta Declaration Greece MoH Xanthos’ proposed next steps ✱ “International convention” to set a regulatory framework to "armour" the procedure in legal terms as well as the result of the negotiation; proposed • Clear process for horizon scanning and negotiations • Clear rules for transposition of decisions at national level • Impartiality and confidentiality ✱ Overcome companies' "unwillingness”, e.g. no parallel procedure ✱ Reinforce technical workstream (VTechnicalCommittee) ; better exchange of information (clinical trials, epidemiological data, target populations, comparable clinical evaluations etc.) ✱ Roadmap with ultimate target of common negotiation to overcome internal divergences and technical issues, e.g. maximum or minimum price, prices range or fixed price, ability or not to conduct negotiations at a national level after the conclusion of the procedure within the "Valletta"). 11 VALETTA DEclaration Greek MoH Xanthos’ quote “ We are forced to break the limits. "Valletta" can and must constitute the successful "example" of voluntary co-operation that will affect the present negative correlations in Europe in a catalytic manner (mainly to the opposition of Germany and the other countries, to any idea of common policies for Health and Medicinal products). We have nothing to lose, we do not have the luxury of the "loner course" against "coalitions of interests" with a huge financial and political influence, we are obligated to maintain a climate of high – and not least – expectations for the citizens of our countries. “ 12 VALETTA Declaration Declarations following 5th Meeting 10-11 July 2018, Athens Romania • Interest in access to innovative medicines, common mechanisms for MoH Sorina Pintea HTA and common negotiations. and State Secretary • Agreed on the need of having more relevant and tangible solutions, Octavian supported the Greek proposal Alexandrescu. • Availablity is a key RO EU presidency topic (from January 2018) Malta “It is in our interest to collaborate since we face common problems, we face the same needs and therefore we can find common solutions through collaborating with the pharma industry – gaining a lot. The Greek proposal is important since it allows for processes acceleration.” 13 External Industry Public Policy Principles (July 2018) Key principles ✱ Depending on circumstances, there might be instances where cross-country initiatives could improve patient access to medicines and others where the optimal outcome may be reached through national procedure; ✱ Industry would support the option that is bringing the optimal result in terms of timely and effective access to innovative treatments. Positioning based on 5 key principles on: ✱ Horizon Scanning EFPIA/Industry 5 principles for collaboration (Dec. 2016) ✱ Joint Clinical Assessment and HTA 1. Broader & accelerated patient access ✱ Information Sharing and Price negotiations 2. No extra process burden (replace equivalent steps in countries) 3. For similar/close countries (economic/health/geographic) ✱ Public Procurement 4. Voluntary 5. Guaranted confidentiality 14 Overall Assessment Summary European Commission Competition Commissioner Margrethe Vestager made a declaration supportive of joint negotiations at a WHO meeting on 20 August 2018. The EC organized with OECD support a ‘Workshop on Building Capacity for Pharmaceutical Negotiations in the EU’ on 19 October 2018. BeneluxA-I The International Horizon Scanning Initiative (IHSI) is moving forward with 16 countries interested, and is to be granted legal personality under the form