1. Quality optimisation in the framework of public tenders Annabelle Bruyndonckx 8 th Belgian Hearth Rhythm Meeting Brussels, 3 October 2014

2. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 1 / L_LIVE_EMEA2:10481810v1 Agenda

3. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 2 / L_LIVE_EMEA2:10481810v1 Agenda I.Preliminary considerations II.How to maintain quality of products and health care in a public tender environment?

4. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 3 / L_LIVE_EMEA2:10481810v1 I.Preliminary considerations

5. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 4 / L_LIVE_EMEA2:10481810v1 I.Preliminary considerations 1.Why a public tender legislation? Late implementation of European Directives  Directive 2004/18/EC on the coordination of procedures for the award of public work contracts, public supply contracts and public service contracts  directive relating to the conduct of public procurements processes  Directive 89/665/EEC relating to the application of review procedures to the award of public supply and public work contracts  directive relating to the rights to challenge the conduct of procurement processes New Belgian public tender legislation entered into force on 1 July 2013 Key elements of public tenders: competition, equal treatment, transparency and motivation Specifics of the healthcare sector are not taken into account by the public tender legislation, which is very general To be implemented in Member States by 31 January 2006

6. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 5 / L_LIVE_EMEA2:10481810v1 I.Preliminary considerations 2.How does the new public tender legislation impact the healthcare sector? Significant impact on the purchase of medical devices/medicinal products by public and private hospitals Hospitals are considered as “contracting authority” subject to the public tender legislation when their activities are mostly (i.e. on a yearly basis more than 50% of the total income) financed by the State, regional or local authorities or other bodies governed by public law (which include RIZIV-INAMI reimbursements) Public tender rules apply on all purchases made by public and private hospitals > €8,500 excl. VAT

7. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 6 / L_LIVE_EMEA2:10481810v1 I.Preliminary considerations Depending on the value of the products/services to be purchased different procedures and rules apply: –Between €8,500 excl. VAT and €85,000 excl. VAT: negotiated procedure without publication –Between €85,000 excl. VAT and €207,000 excl. VAT: Belgian public tender –Above €207,000 excl. VAT: European public tender Yearly purchases of cardiac implants by hospitals exceed €85,000 excl. VAT  Choice of supplier(s) of cardiac implants is subject to public tender legislation Healthcare professionals concerns: less choice of products, lower quality of products, quid therapeutic freedom of physician?

8. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 7 / L_LIVE_EMEA2:10481810v1 II.How to maintain quality of products and health care in a public tender environment?

9. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 8 / L_LIVE_EMEA2:10481810v1 II.How to maintain quality of products and health care in a public tender environment? 1.Do not wait for the launch of a public tender procedure and choice of supplier(s) by hospital purchasing bodies, rather be involved in the preparation of the public tender

10. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 9 / L_LIVE_EMEA2:10481810v1 II.How to maintain quality of products and health care in a public tender environment? 2.How to be involved?  Via the “Medical Equipment Committee (Comité du Matériel Médical/Comité Voor Medisch Materiaal – “CMM”)  CMM decides which types of medical devices must always be available in the hospital to answer patients and healthcare providers’ needs, taking into account practical experience and scientific knowledge  In principle during discussions at CMM financial aspects are not yet considered

11. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 10 / L_LIVE_EMEA2:10481810v1 II.How to maintain quality of products and health care in a public tender environment?  By discussing needs with hospital pharmacists (which are members of the CMM) and with purchasers who will have to ensure that the choices of the CMM are taken into account in the tenders documents  By being involved in the panel who will (i) validate the public tenders documents, (ii) evaluate the criteria and (iii) draft the awarding report

12. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 11 / L_LIVE_EMEA2:10481810v1 II.How to maintain quality of products and health care in a public tender environment? 3.Tool developed by BeHRA?  Examples of standard clauses to be included in public tenders documents (French and Dutch versions available on the website)  Procedure suggested: Call for tender for the award of a framework agreement (Appel d’Offres pour la conclusion d’un accord – cadre / Offerteaanvraag voor het sluiten van een raamovereenkomst)  Flexibility:  Organisation of future orders without any specific purchase commitment  The framework agreement set out, for a maximum of 4 years, terms and conditions under which purchases can be made  Allow the hospital to choose more than 1 supplier i.e. 3 or more suppliers

13. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 12 / L_LIVE_EMEA2:10481810v1 II.How to maintain quality of products and health care in a public tender environment?  Objective of the tool: suggest type of procedure to be followed and criteria to be included when choosing supplier(s) in order to avoid that the products chosen by the hospital do not meet the quality criteria you require  Extracts of the tool relating to the “award criteria” First criteria: quality of the products: 55 points Second criteria: after sale services: 15 points Third criteria: research and developments: 10 points Fourth criteria: price: 20 points 100 points

14. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 13 / L_LIVE_EMEA2:10481810v1 II.How to maintain quality of products and health care in a public tender environment?  What is meant by “Quality of the products” (first criteria)? 1.Technical and clinical value of the products including their reliability and innovative character (25 points) 2.Safety and ease of use (5 points) 3.Materiovigilance (10 points) 4.Training services (technical assistance in the operating room) and information (10 points) 5.Logistic services (orders management, consignment, putting at disposal of equipment, notably programmers and their consumables) (2,5 points) 6.Environmental considerations of the supplies (packaging, waste, etc.) (2,5 points) 55 points

15. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 14 / L_LIVE_EMEA2:10481810v1 II.How to maintain quality of products and health care in a public tender environment? 4.Therapeutic freedom of the physician  Remains to some extent  If for a specific patient or group of patients the physician can justify in the best interest of the patient’s health the choice of a product other than the ones supplied in the framework of the tender  use of negotiated procedure

16. © Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities. 15 / L_LIVE_EMEA2:10481810v1 Annabelle Bruyndonckx 0032 2 542 09 64 annabelle.bruyndonckx@ simmons-simmons.com QUESTIONS? Thank you for your attention