Greece
Needs Assessment
Summary
In the following paragraphs, we present a summary of the questions and issues that
were pointed out by a number of relevant stakeholders, who participated in the needs
assessment survey. A more detailed presentation, along with the names of the
participants, is also given in the attached document.
Part 1) Information of most interest
Description of the existing systems in every member state concerning
pharmaceutical distribution and care
a. Structure of the systems
- Competent Ministries / departments / organizations / institutes and
their official objectives and responsibilities (licenses, prices,
reimbursements, policy-making, monitoring and evaluation).
- Social security agencies and their roles / population coverage /
pharmaceutical care policies.
- Funding system.
- Legal framework (Controlled / mixed / free systems).
b. Pharmaceutical market figures for the last five years
- Description of the pharmaceutical market (total sales / consumption,
respective figures by therapeutic categories / ATC system, main trends,
annual price increases).
- Size and characteristics of domestic pharmaceutical markets.
- Shares of patented, generics and OTCs.
- Parallel imports / exports and their share.
- Pharmaceutical imports and exports.
- Demographic and other relevant figures of each country (e.g.
pharmaceutical companies, wholesalers, pharmacies).
c. Pharmaceutical policy issues
- Prescription / clinical guidelines and agencies responsible for their
establishment.
- Limitations (promotion limitations, prescription limitations,
prescription guidelines / responsible institutes / compulsory coverage,
main categories of dispensation limitations).
- Legal framework for the pharmaceutical dispensation and
reimbursement in public and private hospitals.
- Generic promotion / generic substitution.
- Degree of substitution of older, cheaper medicines by newer, higher
priced.
- Measures to compensate for drug withdrawals due to very low prices.
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Part 2) Key priority areas
1. Pricing
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Responsible department / organization / institute.
Description of the national pricing systems:
i. Legal framework.
ii. Legal procedures / timetable.
iii. Price building (systematic description of margins, scale profit
margins, taxes, VAT, dispensation fees, reference prices).
iv. Pricing formation for innovative, patented, generics, brand
generics, OTCs, orphan and hospital medicines.
v. Exemptions from pricing system.
vi. Reference prices (criteria, basket).
vii. Price reviews (procedures and timetables).
Relation with the licensing and reimbursement procedures.
Usage of cost-benefit analyses for innovative products pricing.
Role of pharmaco-economics in pricing decisions.
Role of bioequivalence studies in pricing formation.
Role of competition in the specific market (if it exists – e.g. discounts).
Official price lists and ways of accessibility.
Techniques / methods of evaluating pricing systems.
2. Reimbursement
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Responsible department / organization / institute / committee and their
role.
Description of the national reimbursement systems:
i. Legal framework.
ii. Description of the system (type of the system /positive negative list, included indication or distribution limitations).
iii. Criteria (economic, therapeutic, pharmacological).
iv. Exempt categories (OTC / others).
v. Description of the reference prices (definition / structure /
methods of clustering).
vi. Legal procedures / timetables.
vii. Compliance.
The role of social security agencies in the reimbursement system
(executive, legislative, involvement in policy – making).
Reimbursement regulations for specific categories (orphan drugs,
hospital drugs, irreplaceable medicines which are not included in the
list, medicines for indications which are not approved).
Usage of negotiations in reimbursement system (framework).
Role of pharmaco-economics in reimbursement decisions.
Co-payment regulations (contribution percentages, exempt population
groups, special pharmaceutical categories / orphan drugs).
Procedures and timetables for decision reviews.
Official reimbursement lists and ways of accessibility.
Techniques / methods of evaluating reimbursement systems.
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3. Cost containment / equality of access
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Recent cost-containment measures and their evaluation (positive /
negative consequences of the regulations).
Methods of evaluation and reviews.
Responsible ministries / departments / institutes.
Cost containment measures that have been proved successful
concerning control of expenditures and equality of access.
3. Monitoring / evaluation
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Responsible departments / institutes (sources, coverage, transparency,
publications).
Methods (electronic / other) for monitoring and evaluation.
Methods for prescription monitoring and evaluating.
Techniques and indicators that have been used for monitoring and
evaluating the efficiency and the efficacy of the pricing and
reimbursement systems.
Part 3) Additional Comments
It is essential for the final report to ensure the consistency and comparability of
the figures included (e.g. pharmaceutical market figures, prices, mark ups). This
has to be taken into account in the development process of the template for
Pharma Profiles.
Finally, the importance of updating the information on the issues mentioned
above, as well as recording and disseminating the effects of new measures taken
was stressed by all the participants in this survey.
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