National Tender Systems

1
National Tender Systems

• An Overview
• Brian OMahony
• WFH Global Forum
• Montreal,
• September 2005

2

• Steps in a Tender Process
• Procurement Rules
• Tender Commissions
• Selection Criteria
• Examples
• Advantages, Disadvantages

3
Developing a Tender Process

• Decide on Contracting Authority
• Establish Tender Commission
• Single, Dual Tier
• Composition
• Terms of Reference
• Product Remit
• Reporting Relationships
• Procedures
• Liability

4
Tender Commissions

• Model 1 - 2 Tier
• (a) Scientific advisory group
• (b) Tender commission, Acts on advice from
• scientific advisory group
• - Brazil, Uruguay
• - Degree of overlap essential
• Model 2 - Single integrated commission
• - Ireland, England, Canada

5
Tender Process

• A. Does tender fall within remit of the
  commission
• - Products
• - Thresholds
• B. Category of Product Specified
• - Plasma Derived
• - Recombinant
• - Both

6
Tender Process

• C. Type of Tender Procedure
• - National Procurement Rules
• - EU Tenders
• E.U. Directive 2004 / 18 / EC
• Government Departments / Agencies
• with gt 50 funding from government

7
EU Tender

• Criteria
• - Price
• - Most Economically Advantageous (MEAT)
• Methods
• - Open - Competitive Dialogue
• - Restricted - Negotiated

8

• Open - Any company may apply
• Restricted - Specific elements of design /
• intellectual input required
• - Particular firms invited to
  tender
• A. Expressions of interest
• B. Tender documents sent to qualifying
• companies

9

• Competitive Dialogue
• - Pre qualified by restricted procedure
• - Dialogue with minimum of 3 companies
• - MEAT Criteria
• Negotiated
• - Exceptional circumstances
• - Only 1 suitable company
• - No tenders / irregular tenders received

10
Tender Process

• D. Selection Criteria
• - Price
• - Most economically advantages (MEAT)
• - Number of suppliers

11
Most Economically Advantageous Tender

• Tender scored against pre stated criteria
• Criteria stated in advertisement or tender
  document
• Detailed criteria and weighings listed or in
  descending order of importance

12
MEAT-Selection Criteria

• Safety, Quality, Efficacy
• Supply
• Cost
• Scientific, Technical Support
• Range of Products
• Consumer, Physician preference
• Mix of Products

13
Tender Process

• E. Score Sheets
• - Use selection criteria to assign
  scores and
• weighing factors to each criteria, sub
  criteria
• - Price is a criteria
• - Prepared prior to receiving tenders
• - Include in tender document

14
Criteria Score Sheets

• Ireland
• Recombinant FVIII, FIX 2003
• Safety - 80
• Efficacy - 30
• Purity - 9
• Supply/Availability - 18
• Scientific Support - 10
• Cost - 8

15
Recombinant FVIII, FIX 2003

• Safety - Albumin as stabiliser
• - Protein in culture medium
• - Murine MAB
• - Viral inactivation
• - Inhibitors
• - Other
• Efficacy - Recovery
• - Clinical Response

16
Recombinant FVIII, FIX 2003

• Supply/Availability
• - Number manufacturing plants
• - Security of supply
• Scientific Support
• - Clinical opinion
• - Consumer opinion
• - Tender documentation
• Cost

17
Tender Process

• F. Quantity Purchased, Term of Tender
• - Clinical requirements over specified
  time
• period
• - Build in flexibility
• Minimum purchase
• Option to purchase additional amount
• Variation
• - Term
• 3 months 3 years

18
Tender Process

• G. Process and Timelines
• - Time limit for expressions of interest
• - Time limit for receipt of tenders
• H. Receipt of Tenders
• - Time, date stamped
• - Procedures for opening tenders
• - No late receipt

19
Tender Process

• I. Tender Commission
• - Confirm valid tenders
• - Seek clarification, further information
  if
• required
• - Presentations based on criteria, optional

20
Tender Process

• I. Tender Commission
• - Criteria may not be altered post tender
  
• documents
• - No post tender negotiation on price
• - Additional information, time, deadlines to
  all
• companies

21
Tender Process

• J. Decision
• - Score each product for each sub criteria
  on score
• sheets
• - Rationale for scores noted
• - 1 Stage Score all criteria
• - 2 Stage Score all criteria except price
• - Products which meet required standard for
  
• safety, efficacy, criteria, then scored
  on price

22
Tender Process

• K. Communications of Decision
• - Decision communicated without delay
• - Short interval before contacts awarded
• - Debriefing meeting with companies

23
Tender Process

• L. Publication of Results
• - EU, within 48 days
• M. Conflict of Interest Policy
• N. Disclosure of Information
• - Confidential information
• - Confidentiality agreements
• - Freedom of information legislation

24
Tender Process

• O. Committee Work Between Tenders
• - Reports on product use, adverse events
• - New information on products
• - International trends
• - Depends on Terms of Reference

25
Ireland

• - HPSMAB Statutory
• - Clinicians, I.H.S., Regulator, Virologist
• Blood Transfusion, Government Officials,
• Contracting Authority
• - Score Sheets
• - Number of supplies specified

26
Ireland

• - Company presentations
• - Debriefing meetings
• - Monitoring of developments regularly

27
Canada

• - Selection advisory committee
• appointed by CBS
• - Legal, safety, regulatory, procurement
• expertise
• - CHS, Immune deficiency organisation
• - Clinicians

28
Canada

• - Score sheets
• - Meetings with companies
• - Number of suppliers specified
• - 90-95 requirements met by tender

29
England

• - Committee under auspices of purchase and
• supply agency PASA
• - PASA, Clinicians, Haemophilia Society,
• Regional Health Authorities.
• - MEAT Criteria
• - Each centre director may select products
• they wish to use

30
Brazil

• - Ministry of health / ANVISA
• - 2 Tier System
• Tender commission officials
• Workgroups on coagulopathies
• - 6 Clinicians
• - 1 Haemophilia Society

31
Brazil

• Workgroup on Coagulopathies
• - Specify safety, efficacy, purity
• - Specify type of concentrates to purchase
• Commission
• - Advertise, handle tender process
• - Decide

32
Brazil

• - No overlap between tiers
• - Technical criteria not always followed
• - Operation Vampire

33
Uruguay

• - Tender committee appointed by Minister
• for Health
• - Officials Accountant, Notary
• - 2 Technical Advisors
• Set criteria on safety, efficacy, purity

34
Uruguay

• - Technical advisors, advise
• - Tender committee, decides
• - Overlap communication at all stages
• - If specified criteria met, final decision
  on price

35
National Tenders - Advantages

• Broad Based Tender Commission with
• Appropriate Expertise
• - Better award criteria
• - Better analysis of criteria
• - More expertise than individual hospitals,
• clinicians, officials, insurance companies

36
National Tenders - Advantages

• - Improved comparative assessment of the
• products
• - Price placed realistically on list of
  criteria
• not sole criteria
• weighing depends on resources
• - Assists in development of higher
  standards of care nationally

37
National Tenders - Advantages

• - National assessment of demand and use
• - National budget
• - Cost effective
• - Contingency Planning flexibility
• - Stakeholder Buy-In

38
National Tenders - Disadvantages

• - Limits range of products available
• Number of suppliers
• Clinicians may use other licensed
  products
• - Limits clinical freedom
• - Unsuccessful company may withdraw
  from country
• Limiting future choice

39

• Formal involvement by leading clinicians and
• National Haemophilia Organisations in Tender
• Committee is vital
• - Selection criteria
• - Knowledge based decisions
• - Confidence