Innovate with us! RELIEF OPEN MARKET CONSULTATION

Transcription

1 Innovate with us! RELIEF OPEN MARKET CONSULTATION

2 AGENDA SECTION Welcome coffee and Registration Opening workshop Session RELIEF project Overview Current situation of Chronic Pain (EU) COFFEE BREAK RELIEF common challenge and presentation of defined needs Q&A: Dialogue with the industry Presentation of upcoming events and last Q&A

3 PROJECT OVERVIEW

4 OBJECTIVES Link European health procurers Establish and execute an agreed Pre Commercial Public Procurement (PCP call for tender) Identify new ICT solutions to support chronic patients in the management and relief of their pains. Foster access to market of ICT solutions and improve healthcare systems and patients empowerment Call: H2020-PHC-2015-single-stage (HORIZON 2020) Topic: PHC Self-management of health and disease and patient empowerment supported by ICT Duration and starting date: 39 months - 1st February 2016 Consortium: 6 partners from Spain France and Sweden

5 CONSORTIUM

6 BUYER S GROUP EXPERIENCE EUROPEAN LEVEL FP7 Program CIP Program H2020 Program NATIONAL LEVEL Public CPB 245 members : Public and Private non profit 2015: 850 M Procurement volume European Projects involved in: National Activities: Launching of public tenders Launching of innovative tenders Public Procurement Consulting service Coordination of the establishment of the GHT Involved in several national projects Innovation procurement

7 BUYER S GROUP EXPERIENCE EUROPEAN LEVEL H2020 FUNDS NATIONAL LEVEL 9.5M funding Ministry of Economy and Competitiveness with ERDF. STARS PCP H2020 PROJECT (Recently funded) ONCOVER BROCA CELL PRESERVATION

8 THE CHALLENGE How could we improve selfmanagement of chronic pain patients with innovative ICT technologies?

9 INNOVATION PROCUREMENT

10 WHAT IS INNOVATION PROCUREMENT? Public procurement is the process whereby public buy goods and services or commission work. SOME FACTS Public procurement delivers solutions to challenge of public interest. Public authorities responsible for tackling Grand Challenges have a strong rationale for addressing market failures from the demand Side. PPI is a demand-side policy instrument in relation to innovation. TWO DIFFERENT MECHANISMS SUPPORTED BY EC o o PPI: Public procurement of innovation is used when challenges can be addressed by innovative solutions that are nearly or already in small quantity in the market and don't need new Research & Development (R&D). PCP: Pre-commercial procurement can be used when there are no near-to-themarket solutions yet and new R&D is needed. PCP can then compare the pros and cons of alternative competing solutions approaches. This will in turn enable to de-risk the most promising innovations step-by-step via solution design, prototyping, development and first product testing.

11 PPI VERSUS PCP PPI Challenge requieres solution which is almost on the market. No R&D involved. Public sector acts as launching customer (not widely commercially avaliable yet). After potentially a test / certification labelling, the buyers group buys a significant volume of solutions. PCP Challenge requires R&D to get new solutions developed. No commitment to deploy (PPI) yet. Public sector buys R&D to steer development of solutions to its needs. Public sector buys R&D from several suppliers in parallel in form of competition evaluating progress after critical milestones, risks & benefits of R&D shared with suppliers to maximise incentives for wide competition.

12 PUBLIC PROCUREMENT OF INNOVATION PROCESS

13 PRE-COMMERCIAL PROCUREMENT (PCP) SOME FACTS R&D services procurement instead of commercially available solutions. Promoting innovation. Procuring in competitive phases to identify the solutions offering the best value for money. Open to all EU interested entities: transparent and nondiscriminatory approach. Sharing of IPR related risks and benefits under market conditions. Implemented by means of a framework agreement with specific contracts for each of the R&D Phases. Open Market consultation to receive industry feedback

14 PRE-COMMERCIAL PROCUREMENT (PCP) LEGAL FACTS Exempted from the EU Public Procurement Directives: procurers do not retain all the benefits of the R&D. Exempted from the WTO Government Procurement Agreement (GPA): this agreement does not cover R&D services. PCP does not constitute state aid under EU state aid rules it follows open, transparent, competitive procedure with risk and benefit-sharing at market price.

15 OPPORTUNITY FOR THE INDUSTRY More open to SMEs and join proposals Opening new markets Developing and commercializing NEW products and services Freedom to propose innovative ideas to be tested in REAL sites Sharing of IPR- related RISKS AND BENEFITS under market conditions R&D process funded by the clients in a competitive phased tender Positioning and learning in Innovation Procurement

16 PCP STAGES PREPARATION STAGE RESAH, CCU and SAS have defined common unmet needs that requires new research and development Co-creation workshop Interviews with patients and health care providers Discussion at consortium level Open market consultation to present the challenge and the RELIEF PCP: PIN (Prior information notice) published on TED Workshops On-line questionnaire Bilateral meetings EXECUTION STAGE PCP Launch Joint procurement of the R&D services Validation/comparison of the performance of the competing PCP solutions against jointly defined criteria in real-life operational conditions.

17 RELIEF PHASES PRE-COMMERCIAL PROCUREMENT COMMERCIAL PROCUREMENT PHASE 1 Solution Design SUPPLIER A SUPPLIER B PHASE 2 Prototype Development PHASE 3 Pre-Commecial small scale product/service development Field test PHASE 4 Commercialization Diffusion of product/ service SUPPLIER C SUPPLIER B SUPPLIER D SUPPLIER D SUPPLIER D SUPPLIER E SUPPLIER F SUPPLIER F SUPPLIER G SUPPLIER F SUPPLIER B, D, F or X SUPPLIER G SUPPLIER H Months 6 Months 12 Months TENDER FOR COMMERCIAL DEPLOYMENT

18 RELIEF TIMING EC Call for Tender Review PCP Launch April 2017 Estimated Offers Evaluation September 2017 Estimated Phase A Starting Phase B Starting Phase C Starting

19 PHASE A : SOLUTION DESIGN Feasibility study of selected technologies to verify technical, economic and organizational feasibility. Expected output : report describing the results of the feasibility study and the conclusions for the start of the development activities in Phase B. Duration : 6 months R&D contract budget : ( per proposal) Maximum of 8 tenderers AWARDED Estimated starting date: September 2017

20 PHASE 2 : PROTOTYPE DEVELOPMENT Purpose : to develop the most promising ideas into well-defined prototypes Expected output : participants are expected to deliver Prototype specification Lab demonstration Plan for original development of a limited volume of first solutions and field-testing, Updated cost/benefits evaluation including a preliminary business plan Bugdet : ( per proposal) Maximum of 4 tenderers AWARDED Duration : 6 months

21 PHASE C: PRE-COMMERCIAL DEVELOPMENT Purpose: to verify and compare the solution prototype in real life conditions Expectations: Field test Field test specifications Plan for original development of a limited volume of first solutions and field-testing, Updated cost/benefits evaluation including a preliminary business plan Bugdet: ( per proposal) Maximum of 2 solutions AWARDED Duration: 12 months

22 Phase 4 : commercialization procurement ( not in the scope of RELIEF PCP) Purpose: commercialization of the product or service OUT of the scope of the RELIEF project Choice of the procurer : At this phase it remains for the public body to decide whether to do a commercial procurement, and for companies to commercialize their innovations.

23 RELIEF TENDER

24 ELIGIBLE TENDERERS Open to all types of operators (companies or other type of legal entities) from any country, regardless of their geographic location, size or governance structure. Single entity or joint tender offer ( consortia) Subcontracting is possible: up to 49 % of R&D *Participation in the open market consultation is not a condition for submitting a tender

25 EXCLUSION CRITERIA Bankruptcy Conflict of interest No conviction for an offence relating to professional practice Professional misconduct Obligations relating to tax, etc. Tenderers that do not comply with these criteria will be excluded.

26 SELECTION CRITERIA Ability to perform R&D up to original development of the first products or services and to commercially exploit the results of the PCP, including intangible results in particular IPRs : Financial and organizational structures : A minimum of liabilities, etc. Capacity, tools, materials and equipment to : carry out research and lab prototyping and produce and supply a limited set of first products or services suitable for production. R&D service contracts, etc. UNDER DISCUSSION Tenderers that do not comply with these criteria will be excluded.

27 COMPLIANCE CRITERIA Definition of R&D services (EU R&D and Innovation state aid framework) Compatibility with other public financing : DOUBLE FUNDING NOT ACCEPTABLE Place of performance of the contract : at least minimum of 50 % of R&D performed in EU Members States or H2020 associated countries Ethics and research integrity Security Usability and Interoperability Tenderers that do not comply with these criteria will be excluded.

28 INTELLECTUAL PROPERTY RIGTHS (IPR) Declaration of pre-existing rights (Background ): remain UNCHANGED by the PCP, but should be listed in the offer. Ownership of results (Foreground) : Each contractor keeps ownership of the IPRs attached to the results generated during the PCP implementation. BUYERS GROUP have the right to: access results, on a royalty-free basis, for their own use grant (or to require the contractors to grant) non-exclusive licences to third parties to exploit the results under fair and reasonable conditions (without the right to sub-license) IPR call-back provisions: if the bidder fails to commercialize the results within a certain time or abuse of the IPR they will have to transfer the IPR to the buyers

29 AWARD CRITERIA UNDER DISCUSSION Technical quality criteria Business Plan Impact Price *Ensure best value for money: NOT permitted to use either lowest price as the sole criteria, without taking quality into account, or highest quality as the sole criteria, without taking price into account.

30 SUBMITTING OFFERS ELECTRONICALLY SUBMISSION (RELIEF Website) DIFFERENT SECTIONS: ADMINISTRATIVE TECHNICAL (plan, innovation, pre-existing rights, business plan, risk assessment and risk mitigation strategy, etc.) FINANCIAL 2 MONTHS TO SUBMIT OFFERS (PENDING FINAL DECISION. ESTIMATED APRIL 2017) OFFICIAL LANGUAGE IS ENGLISH

31 EVALUATION Opening Committee Evaluation Committee (different expert profiles) 4 STEPS : EXCLUSION CRITERIA SELECTION CRITERIA COMPLIANCE CRITERIA AWARD CRITERIA

32 CONTRACT, MONITORING AND PAYMENT Contracting: framework agreement with specific contracts in each phase Monitoring: During each phase, contract implementation will be monitored periodically and reviewed against the expected outcomes (milestones, deliverables and output or results) for the phases. Payments based on: Satisfactory completion of milestones and deliverables (REQUIREMENT FOR PAYMENT) Does not mean Successful completion: PREREQUISITE FOR PASSING FROM ONE PHASE TO THE NEXT

33 LEAD PROCURER DETAILS RESAH acting as LEAD PROCURER. Contracting authority RESEAU DES ACHETEURS HOSPITALIERS Hospital Procurement Network 47 rue de Charonne, PARIS, France All information related to RELIEF PCP TENDER will be available at: Channels to ask any related tender question will be available.

34 CURRENT EU SITUATION CHRONIC PAIN

35 EPIDEMIOLOGY, IMPACT OF CHRONIC PAIN Telephone survey in 15 countries in Europe > respondents (> 18 years old) 19% reported chronic pain defined as: Duration > 6 months Including the last month and several times during the last week Pain rating > 5 (0-10), 33% reported 8-10 High psychosocial impact: 21% diagnosed with depression 61% less able/unable to work outside the home Only 2% treated by pain management specialist 40% inadequate management of their pain (Breivik et al. Eur J Pain, 2006)

36 PREVALENCE (Breivik et al. Eur J Pain, 2006)

37 DURATION AND PAIN CAUSES (Breivik et al. Eur J Pain, 2006)

38 CAUSES OF PAIN (Breivik et al. Eur J Pain, 2006)

39 IMPACT OF CHRONIC PAIN (Breivik et al. Eur J Pain, 2006)

40 CHRONIC PAIN ACTUAL SITUATION France

41 Chronic pain units organisation in France (from a structural perspective) Research and Treatment Structures for Chronic Pain (SDC): Reference structures for the patient after a recommendation by their general or specialist physicians. Organisation into 2 levels in France: 1) SDC called Consultation : mission to take in charge the patient in a multi professional manner (Medical consultation, psychological nurse, access to a social worker, developing a bio-psycho-social assessment and define a therapeutic project); 2) SDC called Center : should ensure, in addition to the missions mentioned before, the organisation of Multidisciplinary Consultation Meetings for the complex situations (In support to the first level consultation), propose specific treatments based on their level of expertise, propose hospitalisations Certified each 5 years by the ARS based on the DGOS instruction (19 May 2011) It exists paediatric SDC, exclusive or not. However, all the SDC can take in charge the children. At least one SDC of the type Centre should be certified per region The SDC should obligatory be linked to a hospital; non-certified consultations exist in healthcare organisations or eventually healthcare centre.

42 Level of assistance offered by the chronic pain units The treatments dispensed to the patients are different according to the specialities of the practitioner (It can be anaesthesiologists, rheumatologists, neurologists ). Based on the historic and specialities offered by the structures, the treatment can be different from a region to another. Most of the time, the orientation of the patient depend on the contact list of the first practitioner. In Paris region, the predominance of AP HP (Public Assistance Pars Hospital) offer treatments which can be really specialised (migraine in adults and children, post-surgical pain, fibromyalgia... the list can be very long)

43 Classic patient route to reach a chronic pain unit Step 1: The patient is sent by his general physician after a painful path with failure of the classics treatments for a more or less long term, at least 3 months but which can reach 1 year; Step 2: According to the symptoms, several researches are done (Xrays, laboratory tests, electrophysiological...) to make a first diagnosis. Step 3: Base on the conclusion, diverse treatments are put in place: Medicine, physiotherapy, other and not always recognized techniques.

44 Most critical needs in the chronic pain assistance process To be able to orientate based on a real diagnosis: can be really difficult in certain cases even with investigations well conducted. The patient needs to be redirected in the good channel to benefit from the appropriate investigations and classical treatments which have made their proofs. Take in consideration of the pain should be part of the therapeutic treatment of the practitioner. The first contact to a SDC happen if there is a therapeutic fail, most of the time during a long period. The period should not exceed 8 weeks after the conclusion of a therapeutic fail.

45 CHRONIC PAIN ACTUAL SITUATION Based on a country wide survey (NSK/SKL) Sweden

46 Survey- Main objectives Mapping of recourses for structured pain diagnostics, treatment and rehabilitation Impact of the recommendations from the National Board of Health and Welfare 1994 Targets and results regarding care of pain patients on a county/region basis Challenges and opportunities in chronic pain care

47 Main conclusions High level of knowledge and structure of pain management within primary care Lack of structure in processes within primary care as well as specialized care, with large regional differences In many counties/regions there are no multidisciplinary pain clinics or pain centers A need for more physicians, physiotherapists and nurses specialized in pain management

48 Structure A multidisciplinary pain center at regional level (5-6 in Sweden) Including education, research and innovation All aspects of treatment, including multimodal rehabilitation Pain clinics at local/county level (around 18) Multidisciplinary specialist care Rehabilitation Primary care Basic care, first line rehabilitation

49 Patients route to the pain center Most patients handled in primary care Referrals to pain clinics/centers Mainly from primary care Also from specialist care Patients may refer themselves to pain clinics/centers anywhere in the country (not yet widely used)

50 CHRONIC PAIN ACTUAL SITUATION Spain

51 Level of assistance offered by the chronic pain units (REINA SOFIA HOSPITAL CÓRDOBA) Integrated Treatment Process for non-oncologic chronic pain and a Chronic Pain Plan in ANDALUCIA (updated in July 2014) MAINLY FOCUS ON MUSCULOESKELETAL CHRONIC PAIN Input limit: People with pain from any location, skeletal muscle origin, with a duration 3 months, an intensity 4 in EVN, and with one of the following characteristics: Continuous pain. Intermittent pain 5 days a week Final limit: Resolution of pain and / or impact. Marginal Boundaries: People affected by Fibromyalgia (There is a specific Plan) People affected by chronic pain, under 14 years old Surgical procedure associated with invasive techniques Professional team (CHRONIC PAIN UNIT REINA SOFIA HOSPITAL CÓRDOBA) Responsible (mainly Anaesthesiologist) 1 Surgeon (Acupuncture) 1 Primary Care Physician 2 Nurses / 2 Nursing Assistant (IT DEPENDS ON THE UNIT; REMARKABLE LACK OF SOCIAL, REHABILITATION, PSICOLOGICAL PROFILES)

52 Classic patient route to reach a chronic pain unit Patients come to the pain unit from PRIMARY CARE and from SPECIALIST CONSULTANT There is NO specific organized flow. It depends on the physician decision. (PATIENT PROCESS SOMETIMES IS DIFFICULT AND COSTLY BEFORE GETTING AN APPROPIATE DIAGNOSIS AND TREATMENT) The patients have all kind of pain, with no limits (INDEFINITION TYPOLOGY OF PATIENTS) Most common: 96% Non oncological pain 68% Musculoskeletal pain 16% Neuropathic pain 14% Mix pain 2% Vascular and visceral pain LACK OF RESOURCES AND INDEFINITION OF TYPOLOGY OF PATIENST involves the increase of waiting list and prolong the treatment process Patients (AFTER BEING SKILLED IN THEIR PAIN ) are DERIVED TO PRIMARY CARE FOR PERIODIC CONTROLS

53 Most critical needs in the chronic pain assistance process Real implementation of strategies that cover not only pharmacological aspects but also OTHER ASPECTS SUCH AS PREVENTION, INFORMATION, PHYSIOTHERAPY, ETC. BETTER QUALITY OF LIFE Improve the measure and follow up of pain treatments, specially those that requires COMPLEXITY invasive techniques such as neuromodulation, implantable pumps, etc. Improve efficiency of the PAIN UNIT due to limited resources Improve INFORMATION AND EDUCATION IN PAIN to CLINICIANS AND PATIENTS (EMPOWERMENT OF PATIENTS and EFFECTIVE CONTROL OF PAIN BY CLINICIANS) Improve TREATMENT ADHERENCE of patients SELF-MANAGEMENT AND MOTIVATIONAL ASPECTS. LACK OF TREATMENTS EFFICACY INVOLVE OTHER RISKS: 29% of patients (SED) tend to self-medication to relief their pain (bad control. Side effects, etc.)

54 References PAIN PROPOSAL TREATMENT PAIN UNITS. STANDARD AND RECOMMENDATIONS. NON ONCOLOGIC CHRONIC PAIN. INTEGRATED TREATEMENT PROCESS (PAI) PANDHORA STUDY EPIDEMIOLOGICAL SURVEY ON PAIN IN PUBLIC ANDALUSIAN HOSPITALS ANDALUSIAN CHRONIC PAIN PLAN

55 COFFEE BREAK