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

Quality optimisation in the framework of public tenders

Annabelle Bruyndonckx

8th Belgian Hearth Rhythm Meeting

Brussels, 3 October 2014

© Simmons & Simmons LLP 2014. Simmons & Simmons is an international legal practice carried on by Simmons & Simmons LLP and its affiliated partnerships and other entities.

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Agenda


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Agenda

I. Preliminary considerations

II. How to maintain quality of products and health care in a public tender environment?


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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

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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


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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?


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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


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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


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® 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


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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


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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 points100

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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 p

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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


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Annabelle Bruyndonckx0032 2 542 09 [email protected]

QUESTIONS?

Thank you for your attention

Documents

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