EU REGULATORY ASPECTS IN IMPLEMENTING NATIONAL PRICING POLICY

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EU REGULATORY ASPECTS IN IMPLEMENTING
NATIONAL PRICING POLICY

• Vesna Koblar, MD. PhD
• WB expert on Regulatory Affairs

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(No Transcript)
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EU pharmaceutical acquis

• Medicinal products
• Quality
• Safety
• Efficacy
• Clinical Trials
• Economic operators
• Manufacturing
• Wholesaling
• Retail sale

Detailed provisions
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EU pharmaceutical acquis

• Quality, Safety, Efficacy,
• Manufacturing, Wholesale, testing
• Clinical Trials
• Dir. 2001/83/EC Dir. 2001/82/EC Dir.
  2001/20/EC Dir. 2003/63/EC Dir. 2004/24/EC
  Dir. 2004/27/EC Dir. 2008/29/EC Dir.
  2003/94/EC Dir. 2005/28/EC
• CR 726/2004/EC CR 540/1995/EC CR 1662/1995/EC
• CR 2141/1996/EC CR 141/2000/EC CR
  847/2000/EC
• CR 1084/2003/EC CR 1085/2003/EC CR
  2049/2005/EC CR 507/2006/EC CR 1901/2006/EC CR
  1394/2007/EC

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EU pharmaceutical acquis

• Pricing
• Reimbursement

General provisions
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EU pharmaceutical acquis

• Pricing Reimbursement
• Dir. 105/1989/EEC

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Aims

• Availability
• Affordability
• Fair prices
• High level of health protection
• High level of competitiveness of pharmaceutical
  industry

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National drug policy

• Limited resources
• Control of expenses
• National rules
• National patients
• National responsibility

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Marketing Authorisation

• Assessment of Quality, Safety, Efficacy
• Price of product should not influence decision on
  granting marketing authorisation

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Pricing

• EU general rules
• meeting general requirements that enable
  competitiveness of pharmaceutical industry
• National rules
• meeting specific needs

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Dir 89/105/EEC

• Ensuring transparency of national requirements
  concerning pricing and reimbursement
• Ensuring transparency of procedures concerning
  pricing and reimbursement

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Dir 89/105/EEC

• Decisions should be taken within the foreseen
  timeframe
• Decisions are based on objective and verifiable
  criteria
• Decisions, particularly negative decisions should
  be justified, justification should be based on
  objective and verifiable criteria
• Legal remedy and deadlines should be clearly
  stated

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Dir 89/105/EEC

• The directive does not influence national pricing
  policies, methodologies and structures of
  national health systems, except requirements for
• Transparency
• Non discriminatory approach
• Non restrictive approach

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Decisions
MARKETING AUTHORISATION APPROVAL
DECISION ON DRUG PRICE
DECISION ON REIMBURSEMENT
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Dir 89/105/EEC

• NATIONAL PRICING MEASURES SHOULD CONCERN ONLY
  MEDICINAL PRODUCTS COVERED BY HEALTH INSURANCE
  SYSTEME

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Dir 89/105/EEC

• DECISION ON DRUG PRICE IS TO BE ADDOPTED AND
  COMMUNICATED TO THE APPLICANT WITHIN 90 DAYS.

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Dir 89/105/EEC

• IN THE ABSENCE OF A DECISION ON DRUG PRICE WITHIN
  90 DAYS
• APPLICANT IS ENTITLED TO MARKET THE PRODUCTS AT
  THE PRICE PROPOSED

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Dir 89/105/EEC

• IF THE REQUESTED PRICE IS/IS NOT PERMITTED
• DECISION SHALL BE BASED ON OBJECTIVE AND
  VERIFIABLE CRITERIA AND COMMUNICATED TO THE
  APPLICANT TOGETHER WITH LEGAL REMEDIES

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Dir 89/105/EEC

• DECISION ON THE INCREASE OF DRUG PRICE IS TO BE
  ADDOPTED AND COMMUNICATED TO THE APPLICANT WITHIN
  90 DAYS.
• (60 DAYS IN THE CASE OF EXCEPTIONAL No OF
  APPLICATIONS)

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Dir 89/105/EEC

• IF THE INCREASE IS/IS NOT PERMITTED
• DECISION SHALL BE BASED ON OBJECTIVE AND
  VERIFIABLE CRITERIA AND COMMUNICATED TO THE
  APPLICANT TOGETHER WITH LEGAL REMEDIES

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Dir 89/105/EEC

• IN THE EVENT OF PRICE FREEZE
• 1/YEAR 90d REVIEW OF MACROECONOMIC CONDITIONS
  TO ASCERTAIN WHETHER THEY JUSTIFY THE FREEZE

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Dir 89/105/EEC

• APPLICATION FOR DEROGATION FROM A PRICE FREEZE IS
  TO BE ADDOPTED AND COMMUNICATED TO THE APPLICANT
  WITHIN 90 DAYS.
• (EXCEPTIONALLY 60d)
• GRANTED DEROGATIONS SHALL BE PUBLISHED

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Dir 89/105/EEC

• IF THE SYSTEM OF DIRECT OR INDIRECT CONTROL OF
  PROFITABILITY IS IN PLACE, THE FOLLOWING
  INFORMATION SHOULD BE PUBLISHED
• METHODS USED TO DEFINE PROFITABILITY (RETURN ON
  SALE OR RETURN ON CAPITAL

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Dir 89/105/EEC

• PERMITTED RANGE OF PROFIT
• CRITERIA ACCORDING TO WHICH THE RANGE OF PROFIT
  IS ACCORDED AND CRITERIA FOR ALLOWING HIGHER
  PROFITS
• ALLOWED MAXIMUM PERCENTAGE PROFIT

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Dir 89/105/EEC

• DECISION ON REIMBURSEMENT IS TO BE ADDOPTED AND
  COMMUNICATED TO THE APPLICANT WITHIN 90 DAYS.
• DECISION ON PRICE REIMBURSEMENT UP TO 180d

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Dir 89/105/EEC

• IF THE PRODUCT IS NOT INCUDED IN THE LIST
• DECISION SHALL BE BASED ON OBJECTIVE AND
  VERIFIABLE CRITERIA AND COMMUNICATED TO THE
  APPLICANT TOGETHER WITH LEGAL REMEDIES

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Dir 89/105/EEC

• IF THE CATEGORY OF PRODUCT IS NOT INCUDED IN THE
  LIST
• DECISION SHALL BE BASED ON OBJECTIVE AND
  VERIFIABLE PUBLISHED CRITERIA AND PUBLISHED
  TOGETHER WITH LEGAL REMEDIES

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Dir 89/105/EEC

• NATIONAL COMPETENT AUTHORITIES SHALL 1/YEAR
  PUBLISH
• DRUG PRICES
• METHODS FOR PRICING CONTROL
• DRUGS INCLUDED INTO AND EXCLUDED FROM THE SCOPE
  OF HEALTH INSURANCE SYSTEM
• INCLUSION AND EXCLUSION CRITERIA

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Dir 89/105/EEC

• TRANSPARENCY COMMITTEE COMMISSIONS
  CONSULTATIVE BODY
• TO EXAMINE ANY QUESTION RELATING TO THE
  APPLICATION OF THE DIRECTIVE

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FURTHER HARMONISATION

• AIMS BALANCE BETWEEN
• COMPETITIVENESS OF PHARMACEUTICAL INDUSTRY
• HIGH LEVEL OF HEALTH PROTECTION

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FURTHER HARMONISATION

• AREAS
• PRICING AND REIMBURSEMENT
• RELATIVE EFFECTIVENESS
• DISTINCTION BETWEEN THE SCIENTIFIC ASSESSMENT
  AND HEALTH ECONOMIC ASSESSMENT

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FURTHER HARMONISATION

• PRICING AND REIMBURSEMENT
• BALANCE BETWEEN CONTROL OF PHARMACEUTICAL
  EXPENDITURE AND
• REWARD FOR VALUABLE INOVATION

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FURTHER HARMONISATION

• PRICING AND REIMBURSEMENT
• WHAT IS A VALUE?
• HOW TO RECOGNIZE IT AND TRANSLATE INTO PRICING
  AND REIMBURSEMENT DECISION?
• BEST PRACTICES SHARE ON CONTROL OF PHARMACEUTICAL
  EXPENTITURES

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FURTHER HARMONISATION

• RELATIVE EFFECTIVENESS
• AIMED TO COMPARE HEALTHCARE INTEVENTIONS IN DAILY
  PRACTICE AND CLASSIFY THEM ACCORDING TO THEIR
  ADDED VALUE
• BEST PRACTICES SHARE ON METHODOLOGIES

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FURTHER HARMONISATION

• PRICING AND REIMBURSEMENT REMAIN NATIONAL
  COMPETENCE
• NETWORKING IS A NEED

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Conclusion
TRANSPARENT NON-DISCRIMINATORY RULES
EU GENERAL PRINCIPLES NATIONAL POLICY AND
COMPETENCES FURTHER VOLUNTARY HARMONISATION
COHERENT APPROACH AND NETWORKING