The Following Questions and Issues Have Been Pointed out By

Greece

Needs Assessment

(Detailed Presentation)

The following questions and issues have been pointed out by:

-3 Ministries (Ministry of Health and Social Solidarity, Ministry of Development – Commercial Section and Ministry of Employment and Social Protection)

-4 Social Security Agencies (the social security for private employees, the social security for public servants, the social security for commercial navy personnel, and the social security for farmers)

-National Organization for Medicines

-Hellenic Association of Pharmaceutical Companies

-Hellenic Association of Pharmacists

-University of Thessaly (Department of Health Economics and Social Policy)

Part 1

Structure of the national health systems in the member states

-Main organizations / departments and their roles.

-Social security agencies and their roles / Population coverage for pharmaceutical care.

-Is there a central service regulating and/or monitoring all pharmaceutical issues, besides separate agencies, and what are its responsibilities?

-Demographic figures – Residents per pharmacies / hospitals / doctors.

-Funding system (for social security agencies, hospitals and doctors).

-The role of organized patient groups.

-The role of the pharmacists.

Pharmaceutical market figures for the last 5 years in the member states

-Pharmaceutical expenditures (private and public) and as a percentage of total health expenditures.

-Size and characteristics of domestic pharmaceutical markets.

-Shares of patented, generics and OTCs.

-Parallel imports / exports and their share.

-Pharmaceutical imports and exports.

Pharmaceutical policy issues

-Dispensation limitations in general (if any).

-Prescription / clinical guidelines and agencies responsible for their establishment.

-What is the legal framework for the pharmaceutical dispensation and reimbursement in public and private hospitals?

-Generic promotion / generic substitution.

-Who has the authority to prescribe in and out of hospital (apart from doctors)?

-Are doctors allowed to dispense medicines?

-How do doctors prescribe (brand names / substances)?

-Measures taken to ensure the quality of generics.

-What is the legal framework for OTC’s?

-Degree of substitution of older, cheaper medicines by newer, higher priced.

-Measures to compensate for drug withdrawals due to very low prices.

-Are there programmes “Help at home”? How do they function and what are the evaluation and control mechanisms?

Part 2

1)Pricing:

-Responsible department / organization / institute and their role in policy-making issues.

-Description of the national pricing systems (mixed / controlled / free).

-Procedures and criteria of price establishments and timetables.

-Pricing formation for innovative, patented, generics, brand generics, OTCs, orphan and hospital medicines.

-Are there pharmaceutical products dispensed only in hospitals and how are their prices formed?

-Are there pharmaceutical categories exempt from the pricing system?

-Are there reference price systems and how these prices are formed?

-Involvement of reimbursement prices (if any) in price formation.

-Wholesale and pharmacy margins, VAT, discounts.

-Procedures and timetables for price reviews.

-Usage of cost-benefit analyses for innovative products pricing.

-Scale profit margins (especially for expensive drugs).

-Official price lists (printed – electronic) and ways accessibility.

-Is competition allowed in pharmaceutical market (e.g. discounts)?

-Are pricing changes possible regardless of interested pharmaceutical company interference?

-What are the legal price changes after the expiration of the patent?

-Price ratios between package sizes.

-Modification of a prescription drug to OTC.

-Role of pharmaco-economics in pricing decisions?

-Bioequivalence studies and their role in price formation.

2)Reimbursement:

-Responsible organizations / institutions / committees and their role in policy-making issues.

-Is there a central regulating system or the reimbursement status and pharmaceutical care are subjects to social security agencies?

-Methods of insured population compensation by the social security agencies.

-Percentages of insured population contribution to the pharmaceutical expenditures.

-Positive / negative lists. What are the criteria (economic / therapeutic / pharmacological).

-Procedures and timetables for establishing the above.

-Role of pharmaco-economics in reimbursement decisions. Guidelines for their implementation.

-Existing co-payment systems and their evaluation.

-Procedures and timetables for decision reviews.

-Are there discounts from the pharmacies to the social security agencies?

-Can a physician prescribe a drug as irreplaceable if it is not reimbursed?

-Are drugs reimbursed beyond approved indications for specific therapeutic categories?

-Are there negotiations between social security agencies and suppliers (framework)?

-Does the doctor also quantify the cost factor and how this has been applied?

-Reimbursement to the social security agencies from the pharmaceutical industries (if any). Definition of rebate system.

3)Cost containment/equality of access

-Description of national pharmaceutical policies for the last years and projections for the years coming. How do they affect expenditures and reimbursement by the social security agencies? Ways of controlling prescription methods.

-Recent cost-containment measures and their evaluation.

-Government regulations on cost containment.

-Social security agencies regulations.

-Are there control systems throughout the distribution line (doctor, pharmacy, social security)?

-Measures that have been proved successful regarding cost containment in parallel to equality of access.

-Systems for monitoring cost benefit for innovative medicines.

-Status concerning access to innovative medicines in the 10 new member states.

-Profit and budget controls.

-Promotion controls.

4)Monitoring/evaluation

-Procedures followed for monitoring and evaluation.

-Electronic methods used.

-Procedures of prescription monitoring and evaluating.

-Monitoring and control of parallel exports.

-Systems used by the social security agencies to monitor their expenses.

-Techniques used to evaluate the efficiency and the efficacy of the pricing and reimbursement system.

-Indicators used to monitor the success of the pricing and reimbursement systems.

Part 3 Additional Comments

There are many questions of specific interest, which are not included in the above list. The final report should provide for links in order to cover the needs for such information.

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